Adhesiolysis in Chronic Abdominal Pain

North Karelia Central Hospital

Status: Withdrawn

Conditions: Chronic Abdominal Pain

Treatments: Procedure: Placebo-surgery; Procedure: Laparoscopic adhesiolysis

Study type: Interventional

Funder types: Other

Identifiers

NCT01245023

NKCH-Surg-007

Details and patient eligibility

About

Laparoscopic adhesiolysis has been used in treatment of chronic abdominal pain. There has been only one previous controlled study, that stated laparoscopy alone had the same benefits than laparoscopic adhesiolysis. The aim of this study is to compare laparoscopic adhesiolysis with a placebo-procedure in chronic abdominal pain.

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• age 18-65 years
• abdominal pain at least 6 months
• previous abdominal surgery and/or significant abdominal trauma and/or abdominal infection
• ASA class I-II

Exclusion criteria

• psychiatric disorder
• significant other somatic diseases (ASA class III-V)
• refusal to participate

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

0 participants in 2 patient groups, including a placebo group

laparoscopy

Active Comparator group

Description:

laparoscopic adhesiolysis and application of Sprayshield spray to prevent further adhesions

Treatment:

Procedure: Laparoscopic adhesiolysis

placebo-control

Placebo Comparator group

Description:

anaethesia and skin incisions without laparoscopy or related procedures

Treatment:

Procedure: Placebo-surgery