Knot Burial Technique for Rectus Sheath Closure

Knot Burial Technique for Rectus Sheath Closure in Relation to Post Operative Pain in Elective Cesarean Section

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.

Study Overview

• Status: Completed
• Conditions: Cesarean Section Complications
• Intervention / Treatment: Procedure: classical closure; Procedure: knot burial technique

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.

• Study Type: Interventional
• Enrollment (Actual): 358
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt
    • Ahmed Ibrahim

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 40 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: classical closure.; 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; surgical suturing intervention
Active Comparator: 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.	Procedure: knot burial technique; surgical suturing intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
wound assessment for suture granuloma formation	by scar tissue palpation for ( presence ) or (absence) of a forming mass.	one week post operative
early ambulation after cesarean section	by observation and history taking , early ambulation within two hours post operative (yes) or (no)	two hours after delivery
early breast feeding after cesarean section	by observation and history taking, early breast feeding within two hours post operative (yes) or (no)	two hours after delivery

Collaborators and Investigators

• Sponsor: Ain Shams University
• Investigators: Study Director: Nashwa elsaid, prof.Dr, AinShams University; Study Director: Reda Mokhtar, Lecture, AinShams University

Study record dates

Study Major Dates

• Study Start (Actual): May 9, 2019
• Primary Completion (Actual): October 9, 2019
• Study Completion (Actual): October 14, 2019

Study Registration Dates

• First Submitted: October 14, 2019
• First Submitted That Met QC Criteria: November 6, 2019
• First Posted (Actual): November 7, 2019

Study Record Updates

• Last Update Posted (Actual): November 7, 2019
• Last Update Submitted That Met QC Criteria: November 6, 2019
• Last Verified: November 1, 2019

More Information

Terms related to this study

• Other Study ID Numbers: FWA 0000175858

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No