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ISRCTN
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ISRCTN23817011
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ClinicalTrials.gov identifier
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Public title
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Laparoscopic-assisted or -facilitated sigmoidectomy for diverticulitis? A prospective randomised trial
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Scientific title
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Acronym
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N/A
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Serial number at source
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04004
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Study hypothesis
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Laparoscopic assisted and facilitated sigmoidectomy result in equivalent postoperative outcomes.
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Ethics approval
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Ethics Committee of the University of Cologne (ref: 04004)
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Study design
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Prospective, unblinded, single-centre, randomized controlled trial.
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Countries of recruitment
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Germany
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Disease/condition/study domain
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Diverticulitis of the sigmoid colon
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Participants - inclusion criteria
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Indication for elective sigmoidectomy for diverticulitis
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Participants - exclusion criteria
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1. Proven or suspected malignancy
2. Prior major abdominal surgery performed through a midline incision
3. Diverticulitis in association with fistula and abscesses (if diagnosed preoperatively)
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Anticipated start date
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01/06/2004
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Anticipated end date
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01/10/2005
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Status of trial
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Completed
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Patient information material
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Target number of participants
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50
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Interventions
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Group 1: Laparoscopic assisted sigmoidectomy with extraction of the specimen via a 5 cm mini-incision in the lower left abdomen
Group 2: Laparoscopic facilitated sigmoidectomy with laparoscopic mobilisation of the sigmoid colon and conventional resection and anastomosis via a 10-12 cm transverse suprapubic incision
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Primary outcome measure(s)
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Cumulative consumption of piritramid administered over 96 hours using a Patient Controlled Analgesia (PCA) protocol
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Secondary outcome measure(s)
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1. The course of postoperative analgesic consumption over 7 days.
2. Amount of postoperative pain and fatigue. Pain was evaluated daily using a visual analogue scale. It was documented once daily starting on the day prior to surgery and then in the morning of each postoperative day. Fatigue was also measured using a visual analogue scale. Fatigue was measured preoperatively and on days 3, 5, 7, 21 and 42 after surgery.
3. Resumption of bowel activity - the time-point of first passage of flatus and the first passage of stool were documented.
4. Pulmonary function, assessed by measuring Forced Vital Capacity (FVC) and forced expiratory volume in 1 second (FEV1) with a mobile spirometer (Renaissance®, Nellcor Puritan Bennett). Pulmonary function was measured the day before surgery and on days 2, 3, 5, and 7. The postoperative data on pulmonary function for each patient were calculated in relation to the preoperative values.
5. Quality of life, measured using the Gastrointestinal Quality of Life Index. It was determined preoperatively, and on days 7, 21, 42 and after one year after surgery.
6. Satisfaction with the cosmetic result, evaluated using the Body Image Questionnaire. The evaluation was performed at one year after surgery.
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Sources of funding
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Leverkusen General Hospital, University of Cologne (Germany)
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Trial website
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Publications
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Contact name
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Dr
Andreas D
Rink
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Address
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Clinic of Abdominal and General Surgery
Johannes Gutenberg University
Langenbeckstr. 1
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City/town
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Mainz
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Zip/Postcode
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55131
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Country
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Germany
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Tel
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+49 (0)6131 1739 76
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Fax
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+49 (0)6131 1747 3976
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Email
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andreas.rink@ukmainz.de
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Sponsor
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Individual Sponsor (Germany)
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Address
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Dr. Andreas D. Rink & Prof. Dr. Karl-Heinz-Vestweber
Leverkusen General Hospital
Department of General Surgery
Teaching Hospital of the University of Cologne
Am Gesundheitspark 5
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City/town
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Leverkusen
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Zip/Postcode
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51375
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Country
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Germany
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Email
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sponsor@unknown.com
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Date applied
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27/12/2007
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Last edited
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02/04/2008
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Date ISRCTN assigned
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02/04/2008
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