Knot Burial Technique for Rectus Sheath Closure

NCT ID: NCT04156282

Last Updated: 2019-11-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 358 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-05-09
• Study Completion Date: 2019-10-14

Brief Summary

Caesarean section is one of the most commonly performed abdominal operations on women in most countries of the world. Its rate has increased markedly in recent years, and is about 20-25% of all child-births in most developed countries.

The present study was a step to reduce postoperative pain in cesarean sections. Because of the large number of women that undergo caesarean section, even small differences in post-operative morbidity rates due to different techniques could translate into improved health and significant savings of cost and health services resources.

Closing the rectus sheath in cesarean sections with the knots pricking through the skin causes significant postoperative pain, discomfort and delayed ambulation. No comments in literature regarding the best way for closing the rectus sheath in cesarean sections.

AIM/ OBJECTIVES The aim of this study is to assess the efficacy of burying knots beneath the rectus sheath during cesarean section in reducing post operative pain and discomfort.

Study hypothesis:

In women undergoing cesarean sections may or may not burying knots beneath the rectus sheath reduce the post operative pain and discomfort.

Detailed Description

Non absorbable and delayed absorbable monofilament materials require meticulous care to prevent knot slippage.

One common problem that arises from use of these materials is the discomfort caused by the knot pricking through the skin. Although this is a common problem after cesarean section, it is often overlooked and only very few preventive techniques have been described.

This study is to assess the efficacy of burying knots beneath the rectus sheath during cesarean sections in reducing post operative pain and discomfort.

Type of Study : A randomized controlled clinical trial. Study Setting :this study will be conducted at the department of Obstetrics and Gynecology at Ain-Shams University Maternity hospital.

Study time: 2019. Study Population : The study population comprises pregnant women, fulfilling the inclusion criteria, attending to Ain Shams University Maternity Hospital, during the study period, who are planned for cesarean delivery.

Conditions

Cesarean Section Complications

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: DOUBLE

Study Groups

classical closure.

In this group, the rectus sheath closure will be done by simple running continuous sutures with the knots beneath the subcutaneous layer.

Group Type: ACTIVE_COMPARATOR

classical closure

Intervention Type: PROCEDURE

surgical suturing intervention

knot burial technique

The surgeon holds the left angle of the rectus sheath incision with an Allis. Using (Polyglactin 910) suture,The needle is taken from the inside outward on the upper edge.The needle is then taken lateral to the Allis and brought back into the wound by taking it through the inferior edge from outside to inside . A square knot is tied with three or four throws. The needle is then taken out of the wound through the upper edge and continuous running stitches . As the right angle is approached, the angle is held with an Allis. the suture, will be taken through the lower edge, is brought outside the wound and passed between the blades of a closed Allis before taking it inside out on the upper edge. One more bite is taken but this time just lateral to the Allis holding the angle, and the needle is brought back into the wound and to the outside between the edges of the rectus sheath. Using the loop of polyglactin held with the Allis , an Aberdeen knot is tied after removing the Allis.

Group Type: ACTIVE_COMPARATOR

knot burial technique

Intervention Type: PROCEDURE

surgical suturing intervention

Interventions

knot burial technique

surgical suturing intervention

Intervention Type: PROCEDURE

classical closure

surgical suturing intervention

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• Term pregnancy ( more than 37 weeks of gestation ) candidate for transverse incision elective cesarean delivery

Exclusion Criteria

• patient with BMI >30 and fat thickness >3 cm.
• patient with haemoglobin less than 10g/dL
• patient with previous history of septic wound.
• Emergency lower segment cesarean section.
• Patients complaining of premature rupture of membrane.
• Patients need intra abdominal drains post cesarean sections
• Patients with established or gestational diabetes, coagulation defects, hemodynamic instability, septicemia or chorioamnionitis.

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Ain Shams University

OTHER

Sponsor Role: lead

Responsible Party

Aliaa Ibrahim Gaber Elsayed

Principal investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Nashwa elsaid, prof.Dr

Role: STUDY_DIRECTOR

AinShams University

Reda Mokhtar, Lecture

Role: STUDY_DIRECTOR

AinShams University

Locations

Ahmed Ibrahim

Cairo, , Egypt

Countries

Egypt

Other Identifiers

FWA 0000175858

Identifier Type: -

Identifier Source: org_study_id