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Clinical Trial
. 2004 Dec;240(6):984-91; discussion 991-2.
doi: 10.1097/01.sla.0000145923.03130.1c.

Hand-assisted laparoscopic versus open restorative proctocolectomy with ileal pouch anal anastomosis: a randomized trial

Affiliations
Clinical Trial

Hand-assisted laparoscopic versus open restorative proctocolectomy with ileal pouch anal anastomosis: a randomized trial

Stefan Maartense et al. Ann Surg. 2004 Dec.

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.

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Figures

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FIGURE 1. Hand-assisted laparoscopic proctocolectomy.
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FIGURE 2. Trial flow diagram.
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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.
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FIGURE 4. Results of postoperative recovery measured with SF-36 questionnaire (mean ± 2 SEM). The x-axis represents the time when the questionnaires were done, before and after surgery. The gray bars represent the laparoscopic group; the black bars represent the open group. The upper 4 graphs show the scales on which the most important differences were anticipated, viz. physical function, physical as it affects one's role, social function, and bodily pain.
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FIGURE 5. Results of postoperative recovery measured with GIQLI questionnaire (mean ± 2 SEM). The x-axis represents the time when the questionnaires were done, before and after surgery. The gray bars represent the laparoscopic group; the black bars represent the open group.

References

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    1. van Duijvendijk P, Slors JF, Taat CW, et al. Functional outcome after colectomy and ileorectal anastomosis compared with proctocolectomy and ileal pouch-anal anastomosis in familial adenomatous polyposis. Ann Surg. 1999;230:648–654. - PMC - PubMed
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