Knot Burial Technique for Rectus Sheath Closure

NCT04156282 | Completed DMC

• 1 other identifier: FWA 0000175858
• Study Type: interventional
• Target: 358
• Locations: 1 country
• Sites: 1

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.

Conditions

Cesarean Section Complications

Outcome Measures

Primary Outcomes (3)

• changing the post operative pain and discomfort

  by Visual Analogue pain Scale (0) means no pain ,( 10) means sever pain.

  the first twenty-four hours after delivery.

• changing the post operative pain and discomfort

  by Visual Analogue pain Scale (0) means no pain ,( 10) means sever pain.

  one week after delivery

• changing the post operative pain and discomfort

  by Visual Analogue pain Scale from ,(0) which means no pain to ( 10) means sever pain.

  two weeks after delivery.

Secondary Outcomes (3)

• wound assessment for suture granuloma formation

  one week post operative

• early ambulation after cesarean section

  two hours after delivery

• early breast feeding after cesarean section

  two hours after delivery

Study Arms (2)

classical closure.

ACTIVE COMPARATOR

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

Procedure: classical closure

knot burial technique

ACTIVE COMPARATOR

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.

Procedure: knot burial technique

Interventions

knot burial technique PROCEDURE

surgical suturing intervention

knot burial technique

classical closure PROCEDURE

surgical suturing intervention

classical closure.

Eligibility Criteria

• Age: 20 Years - 40 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

Ahmed Ibrahim

Cairo, Egypt

Location

Study Officials

• Nashwa elsaid, prof.Dr

  AinShams University

  STUDY DIRECTOR

• Reda Mokhtar, Lecture

  AinShams University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Model Details: we will analyze 400 candidate for elective cesarean sections, divided into two groups ,each of 200 patients according to the rectus sheath closure:

Study Record Dates

• First Submitted: October 14, 2019
• First Posted: November 7, 2019
• Study Start: May 9, 2019
• Primary Completion: October 9, 2019
• Study Completion: October 14, 2019
• Last Updated: November 7, 2019

Record last verified: 2019-11

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)