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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT02790177
Other study ID # ServicesIMSP
Secondary ID
Status Not yet recruiting
Phase Phase 3
First received May 23, 2016
Last updated May 29, 2016
Start date June 2016
Est. completion date December 2017

Study information

Verified date May 2016
Source Services Institute of Medical Sciences, Pakistan
Contact n/a
Is FDA regulated No
Health authority Pakistan: Research Ethics Committee
Study type Interventional

Clinical Trial Summary

The objective of study is to determine the effect of hyaluronic acid on the formation of post-operative adhesions. It will be a randomized control trial comparing the product against normal saline.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 150
Est. completion date December 2017
Est. primary completion date May 2017
Accepts healthy volunteers No
Gender Both
Age group 12 Years and older
Eligibility Inclusion Criteria:

- All consenting patients between the ages of 12-80, who undergo exploratory laparotomy and stoma formation

Exclusion Criteria:

Previous history of abdominal surgery History of peritoneal dialysis Patients in whom permanent stoma is formed

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Drug:
Hyaluronic Acid

NORMAL SALINE


Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Services Institute of Medical Sciences, Pakistan

Outcome

Type Measure Description Time frame Safety issue
Primary POST OPERATIVE ADHESIONS TO BE EVALUATED BY LAPAROSCOPY AT THREE MONTHS INTERVAL 3 months No