Laparoscopic-assisted or -facilitated sigmoidectomy for diverticulitis? A prospective randomised trial

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN23817011

Enrollment

Registered

2008-04-02

Start date

2004-06-01

Completion date

Unknown

Last updated

2015-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diverticulitis of the sigmoid colon Digestive System Diverticular disease of intestine

Interventions

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 mobil

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Indication for elective sigmoidectomy for diverticulitis

Exclusion criteria

Exclusion criteria: 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)

Design outcomes

Primary

Measure	Time frame
Cumulative consumption of piritramid administered over 96 hours using a Patient Controlled Analgesia (PCA) protocol	—

Secondary

Measure	Time frame
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.	—

Measure

Time frame

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.

—

Countries

Germany

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026