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Completed

NCT Number: NCT04156282

Knot Burial Technique for Rectus Sheath Closure

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.

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Key information

Conditions

Cesarean Section Complications

Age range

20 year–40 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Ahmed Ibrahim

Cairo, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

knot burial technique

Procedure

surgical suturing intervention

classical closure

Procedure

surgical suturing intervention

Primary outcomes

  1. changing the post operative pain and discomfort

    Time frame: the first twenty-four hours after delivery.

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

  2. changing the post operative pain and discomfort

    Time frame: one week after delivery

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

  3. changing the post operative pain and discomfort

    Time frame: two weeks after delivery.

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

Secondary outcomes

  1. wound assessment for suture granuloma formation

    Time frame: one week post operative

    by scar tissue palpation for ( presence ) or (absence) of a forming mass.

  2. early ambulation after cesarean section

    Time frame: two hours after delivery

    by observation and history taking , early ambulation within two hours post operative (yes) or (no)

  3. early breast feeding after cesarean section

    Time frame: two hours after delivery

    by observation and history taking, early breast feeding within two hours post operative (yes) or (no)

Sponsors and collaborators

Lead sponsor

Ain Shams University

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Nov 7, 2019
Registry last updated
Nov 7, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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