An interventional study of knot burial technique and classical closure in Cesarean Section Complications, sponsored by Ain Shams University. Completed at 1 site in Egypt. Open to female participants aged 20 Years to 40 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-11-07.
Sponsored by Ain Shams University · Not applicable, Interventional, and Health services research
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.
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.
Ain Shams University is the lead sponsor of 1,876 studies on the registry; 423 are open to participants now.
Of its 32 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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
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
surgical suturing intervention
changing the post operative pain and discomfort
by Visual Analogue pain Scale (0) means no pain ,( 10) means sever pain.
Time frame: 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.
Time frame: 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.
Time frame: two weeks after delivery.
wound assessment for suture granuloma formation
by scar tissue palpation for ( presence ) or (absence) of a forming mass.
Time frame: one week post operative
early ambulation after cesarean section
by observation and history taking , early ambulation within two hours post operative (yes) or (no)
Time frame: 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)
Time frame: two hours after delivery
Plan to share: No
No publications or documents are linked to this record.
This study is completed, as verified in Nov 2019. You cannot join it, but the record below documents what was studied.
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Ain Shams University