Comparison of Laparoscopic Surgery Versus Open Surgery in the Treatment of Adhesive Small Bowel Obstruction

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

102 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-07-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

Small bowel obstruction is a common reason for surgical admission. Most common reason for small bowel obstruction is adhesions, which account up to 70-80 % of small bowel obstructions. Large proportion of adhesive small bowel obstructions may be treated nonoperatively, but up to 50-60% may need surgical intervention. Current golden standard for surgical intervention is open adhesiolysis. Recently, retrospective studies have provided encouraging results of laparoscopic adhesiolysis for small bowel obstructions. However, no prospective randomized trials have been carried out and retrospective series carries a high risk for patient selection and bias. Although in general laparoscopy has been associated with shortened hospital stay, less pain and reduced mortality, laparoscopic adhesiolysis for small bowel obstruction has been reported to cause iatrogenic small bowel lesions up to 7% of patients. Aim of the study is to compare open adhesiolysis to laparoscopic adhesiolysis. The investigators hypothesis is that laparoscopic adhesiolysis is safe, will shorten the hospital stay, and reduce mortality compared to open approach.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Early Small Bowel Obstruction Following Laparotomy For Trauma

NCT01068340

Small Bowel Obstruction

COMPLETED

Lap Adhesiolysis in Intestinal Obstruction

NCT06446440

Adhesions Bowel

RECRUITING

Laparoscopic Approach in Adhesive Intestinal Obstruction

NCT06799208

Efficacy of Laparoscopic Adhesiolysis

NOT_YET_RECRUITING

Intrabdominal Pressure in Small Bowel Obstruction as a Possible Predictor for the Need of Operation

NCT01934283

Small Bowel Obstruction

UNKNOWN NA

Laparoscopic Assisted or Total Laparoscopic Appendectomy

NCT02673528

Acute Appendicitis

COMPLETED

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Adhesive Small Bowel Obstruction

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Laparoscopic adhesiolysis

Group Type EXPERIMENTAL

Laparoscopic adhesiolysis

Intervention Type PROCEDURE

Open adhesiolysis

Group Type ACTIVE_COMPARATOR

Open adhesiolysis

Intervention Type PROCEDURE

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Laparoscopic adhesiolysis

Intervention Type PROCEDURE

Open adhesiolysis

Intervention Type PROCEDURE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* All patients with clinical and computed tomography-diagnosed adhesive small bowel obstruction AND
* Obstruction is not relieved by conservative methods (nasogastric tube, NPO) including Gastrografin is not passed to colon within 8 hours (48-hour conservative treatment without Gastrografin® is allowed if Gastrografin® is contraindicated (e.g. allergy) or not available)

Exclusion Criteria

* Strong suspicion of strangulation or clinical peritonitis thus indicating an urgent operative intervention
* Earlier confirmed or strongly suspected peritoneal carcinosis
* Earlier confirmed wide diffuse adhesions of abdominal cavity
* Earlier open surgery for endometriosis
* Earlier generalized diffuse peritonitis (not including local peritonitis such as appendicitis)
* Active abdominal malignancy or remission less than 10 years
* Earlier abdominal region radiotherapy
* Earlier obesity surgery
* 3 or more earlier open abdominal operations (not including caesarean section(s))
* Suspicion of other cause for obstruction than adhesions in CT-scan
* Earlier abdominal surgical operation within 30 days
* Earlier surgical operation for aorta or iliac vessels performed through laparotomy
* Crohn's disease
* Anesthesiological contraindication for laparoscopy
* Missing informed consent
* Age less than 18 years or over 95 years
* Pregnancy
* Patient living in institutional care (such as health centre ward), not including retirement homes
* Over 1 week of hospital stay directly prior surgical consultation

Minimum Eligible Age

18 Years

Maximum Eligible Age

95 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No