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Cold Knife Versus Monopolar Electrosurgery in Abdominal Incisions

Primary Purpose

Electrosurgery Versus Scalpel

Status

Unknown status

Phase

Not Applicable

Locations

Study Type

Interventional

Intervention

electrosurgery will be used for abdominal incision

scalpel will be used for abdominal incision

About this trial

This is an interventional supportive care trial for Electrosurgery Versus Scalpel focused on measuring electrosurgery, scalpel, abdominal incision

Eligibility Criteria

20 Years - 70 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Arm Label

electrosurgery will be used inanterior abdominal wall incision

scalpel will be used in abdominal wall incision

Arm Description

to perform benign gynecological conditions , surgeon will need to open anterior wall electrosurgically.

to perform benign gynecological conditions , surgeon will need to open anterior wall sharply.

Outcomes

Primary Outcome Measures

Wound incision time

measure time needed to open anterior abdominal wall in minutes by stopwatch

Wound infection

rate of infection in wound after surgery as inflammation, seroma, heamatoma, gapping, sepsis or fever

Secondary Outcome Measures

Postoperative pain (pain score 2-4 hr postoperative).

using Visual Analogue Scale; the higher scores mean worse outcome

Amount of Analgesia needed during 1st 12 hr after surgery .

dose of analgesia needed

Wound-related blood loss

by weighing towel before and after abdominal wall incision / grams

number of participants with bad scar formation or keloid

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

Full Information

NCT ID

NCT04236401

First Posted

December 23, 2019

Last Updated

February 4, 2020

Sponsor

Al-Azhar University

1. Study Identification

Unique Protocol Identification Number

NCT04236401

Brief Title

Cold Knife Versus Monopolar Electrosurgery in Abdominal Incisions

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

February 2020

Overall Recruitment Status

Unknown status

Study Start Date

March 2020 (Anticipated)

Primary Completion Date

March 2021 (Anticipated)

Study Completion Date

May 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Al-Azhar University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

Brief Summary

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Electrosurgery Versus Scalpel

Keywords

electrosurgery, scalpel, abdominal incision

7. Study Design

Primary Purpose

Supportive Care

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

90 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

electrosurgery will be used inanterior abdominal wall incision

Arm Type

Other

Arm Description

to perform benign gynecological conditions , surgeon will need to open anterior wall electrosurgically.

Arm Title

scalpel will be used in abdominal wall incision

Arm Type

Other

Arm Description

to perform benign gynecological conditions , surgeon will need to open anterior wall sharply.

Intervention Type

Procedure

Intervention Name(s)

electrosurgery will be used for abdominal incision

Intervention Description

electrosurgery will be used to open anterior abdominal wall and electrosurgery will be used for heamostasis also

Intervention Type

Procedure

Intervention Name(s)

scalpel will be used for abdominal incision

Intervention Description

scalpel will be used for abdominal wall incision and thread will be used for haemostsis

Primary Outcome Measure Information:

Title

Wound incision time

Description

measure time needed to open anterior abdominal wall in minutes by stopwatch

Time Frame

at the beginning of each surgery

Title

Wound infection

Description

rate of infection in wound after surgery as inflammation, seroma, heamatoma, gapping, sepsis or fever

Time Frame

after surgery till primary healing of the wound, an average of 15 days after operation

Secondary Outcome Measure Information:

Title

Postoperative pain (pain score 2-4 hr postoperative).

Description

using Visual Analogue Scale; the higher scores mean worse outcome

Time Frame

during first 4 hours after surgery

Title

Amount of Analgesia needed during 1st 12 hr after surgery .

Description

dose of analgesia needed

Time Frame

first 12 hours after surgery

Title

Wound-related blood loss

Description

by weighing towel before and after abdominal wall incision / grams

Time Frame

after opening anterior abdominal wall during each surgery

Title

number of participants with bad scar formation or keloid

Description

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

Time Frame

through study completion, an average of 1.25 year

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

20 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

12. IPD Sharing Statement

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Cold Knife Versus Monopolar Electrosurgery in Abdominal Incisions

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