Cold Knife Versus Monopolar Electrosurgery in Abdominal Incisions

February 4, 2020 updated by: Shimaa Esmail Borhamy Khalaf, Al-Azhar University

Cold Knife Versus Monopolar Electrosurgery for Abdominal Incisions ( Clinical Trial )

the aim of work is to compare the early postoperative and late term wound complication rates between the scalpel and electrosurgery in patients with benign gynecological conditions undergoing abdominal incisions.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

• Study Hypothesis: - Using electrosurgery decrease incision blood loss, decrease postoperative pain, decrease wound time incision, decrease analgesia requirements, doesn't increase wound sepsis.

Type of study: - Randomized controlled trial study (parallel group study with 1:1 randomization) will be conducted at gynecology department of Alzhraa University Hospital of faculty of Medicine for girls - Cairo within 1 year according to sample size. A computer randomization will be generated and held with one of the experimenter, and (n) of black and red card will be used for allocation concealment.

Participants at morning of the operation will be given information about the study aims and written consent will be taken.

Study Type

Interventional

Enrollment (Anticipated)

90

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • All patients scheduled for elective gynecological abdominal surgeries for benign diseases
  • willing to participate in the study.
  • The participants will receive 2 gm cephalosporines preoperative per hospital policy.

Exclusion Criteria:

  • History of receiving antibiotics during the preceding 7 days,
  • chronic medical illness like diabetes, asthma or tuberculosis,
  • patients have anemia,
  • surgically scarred tissues,
  • Immuno-compromised patients,
  • pregnant patients,
  • patients with pacemaker device,
  • patients on anticoagulants therapy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: electrosurgery will be used inanterior abdominal wall incision
to perform benign gynecological conditions , surgeon will need to open anterior wall electrosurgically.
Procedure: electrosurgery will be used for abdominal incision
electrosurgery will be used to open anterior abdominal wall and electrosurgery will be used for heamostasis also
Other: scalpel will be used in abdominal wall incision
to perform benign gynecological conditions , surgeon will need to open anterior wall sharply.
Procedure: scalpel will be used for abdominal incision
scalpel will be used for abdominal wall incision and thread will be used for haemostsis

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Wound incision time
Time Frame: at the beginning of each surgery
measure time needed to open anterior abdominal wall in minutes by stopwatch
at the beginning of each surgery
Wound infection
Time Frame: after surgery till primary healing of the wound, an average of 15 days after operation
rate of infection in wound after surgery as inflammation, seroma, heamatoma, gapping, sepsis or fever
after surgery till primary healing of the wound, an average of 15 days after operation

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Postoperative pain (pain score 2-4 hr postoperative).
Time Frame: during first 4 hours after surgery
using Visual Analogue Scale; the higher scores mean worse outcome
during first 4 hours after surgery
Amount of Analgesia needed during 1st 12 hr after surgery .
Time Frame: first 12 hours after surgery
dose of analgesia needed
first 12 hours after surgery
Wound-related blood loss
Time Frame: after opening anterior abdominal wall during each surgery
by weighing towel before and after abdominal wall incision / grams
after opening anterior abdominal wall during each surgery
number of participants with bad scar formation or keloid
Time Frame: through study completion, an average of 1.25 year
scar condition evaluation after complete healing of the wound. early healing after 15 days of the surgery and after complete healing after 45 days of the surgery
through study completion, an average of 1.25 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Al-Azhar University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

March 1, 2020

Primary Completion (Anticipated)

March 1, 2021

Study Completion (Anticipated)

May 1, 2021

Study Registration Dates

First Submitted

December 23, 2019

First Submitted That Met QC Criteria

January 20, 2020

First Posted (Actual)

January 22, 2020

Study Record Updates

Last Update Posted (Actual)

February 5, 2020

Last Update Submitted That Met QC Criteria

February 4, 2020

Last Verified

February 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Electrosurgery

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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