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Ann Surg. Dec 2004; 240(6): 984–992.
PMCID: PMC1356514

Hand-Assisted Laparoscopic Versus Open Restorative Proctocolectomy With Ileal Pouch Anal Anastomosis

A Randomized Trial
Stefan Maartense, MD,* Michalda S. Dunker, MD, PhD,* J Frederick Slors, MD, PhD,* Miguel A. Cuesta, MD, PhD, Dirk J. Gouma, MD, PhD,* Sander J. van Deventer, MD, PhD, Ad A. van Bodegraven, MD, PhD,§ and Willem A. Bemelman, MD, PhD*

Abstract

Objective:

The aim of the study was to evaluate postoperative recovery after hand-assisted laparoscopic or open restorative proctocolectomy with ileal pouch anal anastomosis for ulcerative colitis and familial adenomatous polyposis in a randomized controlled trial.

Methods:

Sixty patients were randomized for hand-assisted laparoscopic (n = 30) or open surgery (n = 30). Primary outcome parameter was postoperative recovery in the 3 months after surgery, measured by quality of life questionnaires (SF-36 and GIQLI). Secondary parameters were postoperative morphine requirement and surgical parameters, viz. operating time, morbidity, hospital stay, and costs.

Results:

There was no difference between the 2 procedures in quality of life assessment in the 3 months after surgery. There was a significant decline in quality of life on all scales of the SF-36 (P < 0.001) and total GIQLI score (P < 0.001) in the first 2 weeks in both groups (no significant difference between the groups). Quality of life returned to baseline levels after 4 weeks. Operating times were longer in the laparoscopic group compared with the open group (210 and 133 minutes, respectively; P < 0.001). No significant differences were found in morphine requirement. Neither morbidity nor postoperative hospital stay differed between the laparoscopic and open group (20% versus 17%, in 10 versus 11 days, respectively). Median overall costs were € 16.728 for the hand-assisted laparoscopic procedure and € 13.406 for the open procedure (P = 0.095).

Conclusions:

Recovery measured using quality of life questionnaires is comparable for hand-assisted laparoscopic or open restorative proctocolectomy with ileal pouch anal anastomosis. The laparoscopic approach is as safe, but more costly than the open procedure.

Proctocolectomy with ileal pouch anal anastomosis (IPAA) is the preferred surgical option for the treatment of ulcerative colitis (UC) and familial adenomatous polyposis (FAP). Low morbidity rates, good functional outcome, and quality of life have been reported with open surgery.1–4

Since the introduction of laparoscopic colectomy in 1991, the experience in laparoscopic bowel surgery has gradually increased. Improved laparoscopic skills and new instruments have led to broad application in benign and malignant diseases.5–11 Most reports describe case-series of segmental laparoscopic colonic resections performed in a selected group of patients. These reports suggest that laparoscopic colorectal resection is feasible, safe, and an acceptable alternative to laparotomy for a variety of diseases.5,6,10–15 Proctocolectomy with IPAA is one of the most extensive colorectal procedures and performing such an operation laparoscopically is even more demanding. Little is known on the feasibility and safety of laparoscopic-assisted restorative proctocolectomy for UC and FAP. Until now only case-series and some case-control studies have been reported,7,10,12,14,16–18 which showed the feasibility of the procedure in selected patients. The aim of the study was to evaluate postoperative recovery in terms of quality of life after hand-assisted laparoscopic or open restorative proctocolectomy with IPAA for UC and FAP in a randomized controlled trial.

PATIENTS AND METHODS

Patients eligible for an elective proctocolectomy with IPAA for UC or FAP were included in a randomized trial. The trial was conducted in 2 academic medical centers (Academic Medical Center and Vrije Universiteit Medical Center, Amsterdam). The participating surgeons had extensive laparoscopic experience. The surgeons had to have performed at least 20 laparoscopic (sub-) total colectomies, or 20 right-sided and 20 left-sided laparoscopic resections. Furthermore, these surgeons also had to have performed at least 20 pouch procedures. Inclusion criteria were patients with UC and FAP scheduled for an elective procedure and age above 16 years. Exclusion criteria were previous laparotomy, bowel resection, proofed malignancy, or pregnancy. Patients were asked to participate in this study in the outpatient department. After informed consent was obtained and after completing preoperative quality of life questionnaires, patients were randomized. Patients were allocated to one of the 2 groups using sealed envelope randomization. Randomization was performed by an independent research fellow in the Academic Medial Center Amsterdam.

Operative Procedures

Patients were preoperatively prepared with anterograde intestinal cleansing (Klean Prep). Surgery was performed under general anesthesia.

Hand-Assisted Laparoscopic Proctocolectomy

Hand-assisted laparoscopic colectomy was done with the aid of a hand-port, as previously described.8 An 8-cm Pfannenstiel incision was made at the start of the operation. First the sigmoid was mobilized through this incision. After this the laparoscopic part of the surgical procedure was started. First the hand-port was placed in the Pfannenstiel incision (Fig. 1). During the study the Omniport (Advanced Surgical Concepts Ltd., Wicklow, Wicklow, Ireland) was used. Three additional trocars were inserted, one 10 mm below the umbilicus (laparoscope), a 5-mm in epigastrium (for dissection), and one 11- to 12-mm trocar in the lower left abdomen (dissection, stapling, clipping). Under manual guidance mobilization of the large bowel, from sigmoid to cecum with the corresponding dissection of the epiplon was performed followed by vascular division by means of the Ultracision device (Ethicon Endo-surgery, Johnson & Johnson, Amersfoort, Netherlands). Transsection of the terminal ileum was done using an endostapler. After this the hand-port was removed and the colon was taken out through the Pfannenstiel. Transsection of the proximal rectum was done through the Pfannenstiel incision. Via the Pfannenstiel incision the rectum was removed according to the total mesorectal excision principle followed by J-pouch creation. The ileal pouch-anal anastomosis was made according to the double stapling technique.

figure 8FF1
FIGURE 1. Hand-assisted laparoscopic proctocolectomy.

Open Surgical Technique

The details of the technique of this procedure have been described earlier.19,20 In short, a median incision was used. Mobilization of the colon, vascular division and dissection of the greater omentum was done with a similar technique as described above. The rectum was removed according to the total mesorectal excision principle; this was followed by J-pouch creation. The rest of the procedure was similar to the open part of the laparoscopic-assisted procedure.

In both procedures, a protecting loop-ileostomy was done at the surgeon's discretion (eg, difficult dissection, bleeding, severe proctitis, or incomplete donuts after anastomosis, or use of high dosage of steroids).

Postoperative Care

If a patient agreed to the use of patient-controlled analgesia morphine requirement was measured in the first 3 postoperative days, other patients had either continuous morphine infusion or epidural anesthesia during the first 3 to 5 days after surgery. All patients had a 24-Fr Foley catheter inserted transanally in the pouch for 5 days, except for those with a protecting ileostomy. Patients were only allowed to have clear liquids for this period. This was done to prevent jamming of the pouch catheter with stool. The nasogastric tube should be removed the day after surgery. After 5 days, the pouch catheter was removed and the diet was extended to normal diet. Patients were discharged when a normal diet was tolerated and the stool frequency was acceptable.

Endpoints

The hypothesis was that patients that underwent a laparoscopic-assisted proctocolectomy would have a faster postoperative recovery during the first 3 months. Since hospital discharge as end point can be influenced by many subjective factors, postoperative recovery was measured with quality of life questionnaires, the validated SF-36,21 and the total score of the GIQLI.22 The difference in quality of life between the 2 procedures was compared preoperatively and at 1, 2, and 4 weeks, and 3 months after surgery.

Operating time, blood loss, conversion rate, early morbidity, morphine requirement, mortality, and costs were secondary endpoints. Postoperative morbidity was subdivided in minor and major complications. Wound infections, urinary tract infections, pleural effusion, pneumothorax, and deep venous thrombosis were considered minor complications. Intra-abdominal abscesses, bleeding, leakage, sepsis, burst abdomen, respiratory insufficiency, and prolonged ileus were considered major complications. An ileus was considered to be prolonged if patients did not have bowel sounds and/or flatus 5 days after surgery.

Sample Size Calculation and Statistical Analysis

Patients were analyzed according to the intention to treat principle. It has been suggested in the past that a 20% difference in quality of life is clinical significant. The hypothesis was that some subscales of the SF-36 would show clinical significant differences, viz. physical function, physical as it affects ones role, social function, and bodily pain.23–25 Accepting the assumption that 20% is a relevant clinical difference in these subscales (standard deviation of 20%–25%) 4 weeks after surgery; a sample size of 30 patients per group was sufficient to find a statistically significant differences between the open and the laparoscopic-assisted group (α = 0.05, β = 0.1). The same calculation was performed for a 20-point difference in the total GIQLI score after 4 weeks between the 2 groups, again a total of 60 patients was sufficient to show significant differences.

Data are presented in median and range. Groups were compared using the nonparametric Mann-Whitney U test, and the χ2 test when appropriate. For quality of life analysis, a Manova procedure was used. Statistical analysis was performed using the statistical program Statistical Package for the Social Sciences 11.5 for Windows (SPSS, Chicago, IL).

RESULTS

The trial flow diagram is shown in Figure 2. Between January 2000 and August 2003, 60 patients were included and operated. All patients were operated according to the procedure allocated after randomization. Patient characteristics are presented in Table 1. Patients from both groups were equally divided in both groups. Patients who underwent an open restorative proctocolectomy were older than the patients who had a hand-assisted laparoscopic procedure (P < 0.05). There were no conversions and there was no mortality. Results in terms of surgical parameters for the 2 procedures are shown in Table 2. The operation time was significantly longer in the patients operated via a laparoscopic procedure compared with the open procedure, 214 minutes versus 133 minutes (P < 0.001) (Table 2). Blood loss was not different in the 2 groups.

figure 8FF2
FIGURE 2. Trial flow diagram.
Table thumbnail
TABLE 1. Patient Characteristics Before One-Stage Restorative Proctocolectomy With IPAA
Table thumbnail
TABLE 2. Results of One-Stage Restorative Proctocolectomy With IPAA

Eight patients received a primary protecting loop ileostomy in the laparoscopic-group. Two because of incomplete donuts after double stapling, one because iatrogenic perforation of the small bowel, and 5 because of severe proctitis. In the open group, 7 patients had a primary protecting loop ileostomy, 4 because of severe proctitis, and 3 patients because of difficult dissection.

In the laparoscopic-group, 5 patients had major complications, viz. twice anastomotic leakage of the ileal pouch anal anastomosis, and 3 other patients with an ileus. Three patients underwent a relaparoscopy, twice for anastomotic leakage, and in the other patient because of a persisting ileus. These patients were given a protecting loop ileostomy during this relaparoscopy. The other 2 patients with an ileus were treated conservatively. In the open group, 4 patients had a major complication. All 4 had a relaparotomy because of anastomotic leakage, persistent ileus, burst abdomen, and a left instrument. All 4 patients were given a protecting loop ileostomy.

All stomas, 11 patients in both groups, were closed within 3 months, except for 2. One stoma in the laparoscopic group could not be closed due to the fact that the patient developed a cholangiocarcinoma, closing the stoma was not considered to be advisable. In the open group, one stoma could not be closed due to persisting intra-abdominal abscesses. In 1 patient, the pouch was removed 9 months after surgery because of manifestation of idiopathic mesenteric veno-occlusive disease in the pouch.

Postoperative recovery was not different, as measured by postoperative pain, morphine requirement, and return to normal diet (Table 3; Fig. 3). Hospital stay was not different between the 2 groups: 11 days (range, 6–28 days) in the open group versus 10 days in the laparoscopic group (range, 5–24 days) (P = 0.767). Patients that had relaparotomy/relaparoscopy for complications had a hospital stay of 24 days (median). There was no difference according to whether they had laparoscopy or laparotomy. In the “open” patient group, 2 patients had retrograde ejaculation after surgery; fortunately, this was restored with time.

figure 8FF3
FIGURE 3. Postoperative pain as measured with VAS scores (mean ± 2 SEM). The x-axis represents the time after surgery. The gray error bars represent the laparoscopic group; the black error bars represent the open group.
Table thumbnail
TABLE 3. Postoperative Recovery in Terms of Morphine Requirement and Return to Diet

The results of the SF-36, the GIQLI, are shown in Figures 4 and 5. There was a significant decline in quality of life on all scales of the SF-36 (P < 0.001) and total GIQLI score (P < 0.001) in the first 2 weeks. However, this decline was not affected by the type of surgery. Quality of life returned to baseline levels after 4 weeks. Three months after surgery, patients had better QoL scores than before surgery on all scales of the SF-36 and on the total GIQLI score.

Table 4 shows the mean costs for the 2 procedures in the 2 participating centers: costs for material used during the procedure, costs for use of an operating theater with personnel, costs for relaparotomies, and costs for admission days. The calculation of the costs was based on these amounts. Preoperative costs were not taken into account. The median costs for a laparoscopic-assisted procedure, that is, material and use of an operating theater with personnel, were €3.387 (range, €3.070–4.287) and for open surgery this was €1.721 (range, €1.541–2.332; P < 0.001, Kruskal-Wallis). Median overall costs, including relaparotomies, hospital stay, and readmission costs (stoma closure) were €16.728 (range, €8.364–46.468) for the laparoscopic procedure and €13.405 (range, €9.145–45.466) for the open procedure (P = 0.095, Kruskal Wallis).

Table thumbnail
TABLE 4. Costs of Laparoscopic-Assisted or Open Proctocolectomy

DISCUSSION

The present study is the first randomized controlled trial comparing hand-assisted laparoscopic versus open restorative proctocolectomy with IPAA for patients with UC and FAP. Postoperative quality of life was not different for the laparoscopic procedure compared with the open procedure as measured by the SF-36 and the GIQLI. Quality of life decreased significantly immediately after surgery. In the present study, quality of life levels were back at the baseline after 4 weeks. Three months after surgery, quality of life had improved in comparison to the preoperative levels on all scales of the SF-36 and the total GIQLI score. However, this improvement was not significant.

Studies like these are difficult to perform because of logistic aspects. Most colorectal surgeons lack laparoscopic experience, and most laparoscopic surgeons have no experience with restorative proctocolectomy. For this reason, only 2 centers were able to participate in this study.

It has also been suggested by others that these trials can be difficult because many patients are referred for the laparoscopic procedure. Since open restorative proctocolectomy was still considered the standard procedure, laparoscopy was only offered in context of this trial. This partly explains the high percentage of patient accrual in this trial.

After consulting the department of clinical epidemiology, quality of life was chosen as primary efficacy parameter since other outcome parameters are very likely to be biased, for example, return to diet, and in particular hospital stay. Blinding the patient for the type of procedure has been tried (blood-stained wound dresses), in particular for laparoscopic cholecystectomy, however, was abandoned because it turned out to be impossible to hide the type of procedure for the patient, especially after discharge of the patient.

The differences in quality of life between the 2 groups were very limited; while assuming that a 20% difference would be of clinical relevance which was based on earlier reports of Liem et al finding a 20% difference in subscales of the SF-36 comparing open with laparoscopic hernia repair.23–25 The chance to find significant differences in a larger sample size will be limited. The extent of the restorative proctocolectomy itself probably also in combination with the startup problems of the pouch outweighed the advantages of a smaller incision. Similar results in a nonrandomized study were obtained by Thaler et al26; no different results in quality of life were found comparing laparoscopic and open colectomy for benign diseases, particularly not for the long-term results.

In the first published comparative series of laparoscopic-assisted proctocolectomy with IPAA, high morbidity and longer operating time were reported, without any of the supposed advantages of laparoscopic surgery.16 These disappointing results could be due to the learning curve effect. More recent case series and case-control studies showed advantages such as an earlier return of bowel function, shorter hospital stay, and complication rates similar to the open procedure,7,10,12,14,17,18 this at the expense of a longer operating time.

The present study cannot substantiate all of the previous findings. Laparoscopic restorative proctocolectomy is feasible, with a low conversion rate, acceptable operating times, little blood loss, and is safe in terms of postoperative morbidity and comparable to open surgery.15,27,28 However, the hand-assisted laparoscopic procedure takes 1 hour longer than the open procedure, and there are no clear advantages in terms of morphine requirement and postoperative stay. Moreover, median overall costs are about €3000 higher than the open procedure. Interpreting these results, one must realize that all patients without a covering ileostomy had clear liquids for 5 days. This might have biased a possible difference in postoperative recovery.

The actual differences in the 2 surgical techniques that were studied were the approach of the total colectomy viz. hand-assisted laparoscopically versus open, and the approach of the rectum viz. through a Pfannenstiel or via a midline laparotomy. To perform rectal resection through an 8-cm Pfannenstiel incision, a ring retractor had to be placed. This could have been the cause of an equal morphine requirement postoperatively between groups, although the incision in the laparoscopic group was 2 to 3 times smaller than in the open group. A total laparoscopic approach including laparoscopic rectal resection resulting in an even smaller Pfannenstiel incision without the need of a ring retractor might show differences in morphine requirement and hospital stay. Unfortunately, the laparoscopic surgeons did not have sufficient experience in laparoscopic rectal resection at the start of the study.

In literature results of studies reporting costs for laparoscopic and open surgery are conflicting. Recently, Delaney et al29 showed in a case-matched study that direct costs for laparoscopic colorectal surgery were lower than for open surgery. However, in a review Ballantyne30 calculated comparable costs, while Chapman et al31 concluded that laparoscopy was more expensive. In this study, costs for the surgical procedure were significantly higher in the laparoscopic group (P < 0.001). However, overall costs, viz. costs of surgery, personnel costs, costs of hospitalization, and costs of relaparotomies, etc, were comparable for laparoscopy and open surgery (P = 0.095). These results are obtained in a randomized setting and reflect restorative proctocolectomy rather than segmental colectomy. Costs of a laparoscopic procedure greatly depend on the applied technique. Reduction of the use of disposables can be achieved, for instance, by a pure laparoscopic proctocolectomy with a medial approach of the large vessels, where clips, vessel sealing, or ultrasonic devices and electrocautery suffice. A hand-port and endoscopic stapler can be avoided, making the procedure less costly.

One could argue that the results of the present study are disappointing for those who favor the laparoscopic approach. Although hand-assisted laparoscopic proctocolectomy takes more time and is more expensive without substantial benefit in terms of faster recovery, the present study demonstrated that in centers with expertise it can be offered safely to the patients. The obvious advantage of a superior cosmesis of a Pfannenstiel incision compared with the midline incision will be recorded after a follow-up of at least 1 year using the body image and cosmetic questionnaires as described by Dunker et al.32,33 Other potential advantages, such as a lower rate of small bowel obstruction and incisional hernia, have to be awaited.

Discussions

Dr. O'Connell: Thank you for the opportunity to comment on this paper. The aim of this randomized clinical study was to evaluate postoperative recovery after laparoscopic assisted or open restorative proctocolectomy. The primary endpoint was quality of life 3 months postoperatively. There were no differences between the 2 groups. The major issue is whether a laparoscopic assisted technique is sufficiently different in its physiologic insult that one might have expected to see such dramatic differences weeks or months after operation. These were young relatively fit patients who were suitable for elective surgery. My first question is: what, if any, physiological differences were found between the 2 postoperative groups and might your findings might be applicable to a sicker, older cohort such as those undergoing surgery for colorectal cancer? The second question is why the length of stay is so long, because most papers that have addressed the question of laparoscopic assisted colorectal surgery point to the advantage of early hospital discharge. Lastly, I would be interested in your comments regarding loop ileostomy as a number of patients in your study required reoperation for anastomotic leakage.

Dr. Bemelman: Thank you for your comments. In our study, we have looked for more objective outcome parameters than the usual ones like hospital stay and return to normal diet. Based on data of Liem et al who compared open versus laparoscopic hernia repair, we decided to use quality of life measured by the SF-36 at 2 and 4 weeks after surgery as an objective primary outcome parameter. I agree with you that it can be questioned whether recovery after hernia repair can be compared with recovery after restorative proctocolectomy.

Since we have not found any differences between the open and laparoscopic group, one must assume that the impact of the proctocolectomy itself is much higher than the size of the laparotomy used for access. In addition, patients shortly after restorative proctocolectomy have a lot of starting problems getting used to their pouch, which might have influenced their quality of life more than the approach of surgery.

It is correct that our hospital stay is a few days longer than in other nonrandomized studies reporting on (laparoscopic) restorative proctocolectomy. It is our policy to let a pouch drain in for 5 days. Only after removal, oral intake can be advanced to solids and the patients can be fully mobilized. This might extend the hospital stay in patients having restorative proctocolectomy without a covering ileostomy. In addition, median hospital stay was influenced by morbidity due to anastomotic leakage as well. In most reports, all patients have a diverting ileostomy. Advancement to solids and mobilization can be done faster. No prolonged hospital stay is to be expected from anastomotic leakage if the pouch is protected. However, all these patients have to come back for stoma closure and additional morbidity of the ileostomy itself.

With respect to your last question, diverting ileostomy is fashioned only selectively. If we do not feel secure for whatever reason, a diverting stoma is made. Therefore, we accept an overall 6.6% (3 of 45) anastomotic leakage rate, avoiding an unnecessary ileostomy in most of the patients.

Dr. Carlson: Thank you for asking me to comment on this interesting paper. If I have got you right, I understand that in one group the colectomy phase of the operation was performed open and in the other group it was performed laparoscopically, but in both groups the pelvic phase of the operation was performed open. When you add to the fact that a substantial amount of the morbidity is actually associated with the pelvic phase of the operation in this type of surgery, your study may not be as well powered as you thought it was going to be because it has taken away much of the advantage of the laparoscopic arm.

The other issue is the fact that a third of the patients in each arm had a covering loop ileostomy. Much of the early postoperative morbidity is associated with dealing with the loop ileostomy, especially if high output and since a third of the patients in each arms had one, you would again be very hard put to show a significant difference between the 2 groups. I should also add that your length of hospital stay in both arms seems extraordinarily long when compared with similar figures reported from Denmark, and I would be interested to hear an explanation for this.

Dr. Bemelman: It is correct that the actual difference between the 2 study groups was the approach of the colectomy. Rectal resection was done open in both groups, in the laparoscopic groups via an 8-cm Pfannenstiel incision and in the open group through a median laparotomy.

It is possible that a total laparoscopic approach would have showed a difference. At the time of the start of our study, we did not have the laparoscopic expertise to perform a laparoscopic rectal resection and we did not want to change the surgical approach throughout the study.

A selective approach toward covering ileostomy is our policy to avoid readmission for closure and ileostomy-related morbidity, in particular small bowel obstruction. It is my impression that patients with a covering ileostomy probably go home earlier because their intake can be advanced more rapidly to solids and mobilization is easier without a pouch drain. In our study, hospital stay was equal for patients with or without a covering ileostomy. However, one should realize that median hospital stay in the group without a covering ileostomy was increased due to a higher morbidity (ileus and anastomotic complications).

Dr. Johnson: I have a simple question: have you acted on your own conclusions and abandoned laparoscopic proctocolectomy and have you used the spare money for something else, and if so, for what?

Dr. Bemelman: As a laparoscopic colorectal surgeon, I felt a bit disappointed with the results of this study. However, we have indicated that in expert hands laparoscopic restorative proctocolectomy is as safe as the open procedure and can be offered safely to our patients. In this young group of patients, other long-lasting advantages such as cosmesis might be more important than a faster recovery. Considering the overall expenses in health care to improve one's appearance, it is probably worth the additional costs avoiding a midline laparotomy. The only problem is how to decide who will have the laparoscopic approach and who will have a conventional operation.

Footnotes

Reprints: W.A. Bemelman, MD, Department of Surgery, Academic Medical Center, Meibergdreef 9, 1105 AZ Amsterdam, The Netherlands. E-mail: ln.avu.cma@namlemeB.A.W.

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