Low Versus Standard Pressure Pneumoperitoneum

NCT ID: NCT04947982

Last Updated: 2021-07-01

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 230 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-07-01
• Study Completion Date: 2022-07-30

Brief Summary

The role of laparoscopy in gynecological and gyne-oncological surgery has dramatically increased over the past decades. Although laparoscopic procedure has several advantages over open surgery such as reduced blood loss, faster recovery earlier return to normal activities and work, however, postoperative pain and some hemodynamic changes sometimes discomforts the patients, lessening quality of life at postoperative period [1-3]. In clinical practice the majority of laparoscopic procedures are performed using standard pressure pneumoperitoneum (SPP, 12-15 mmHg) [1-3]. These noticeable adverse effects are associated with of creation of pneumoperitoneum with carbon dioxide (CO2) but it is requisite in all laparoscopic surgery for adequate visualization and operative manipulation.

The incidence of pain after gynecologic laparoscopies has been reported to vary from 35% to 63% [4,5]. A randomized controlled trial has demonstrated that there may be more intense pain and greater analgesia requirements in the immediate postoperative period after laparoscopic surgery than after laparotomy [6]. The origin of pain after laparoscopy is multifactorial and complex. It can be differentiated into abdominal pain and shoulder pain [7]. The precise causes for such pain are still obscure. Abdominal pain may be attributed to stretching of the abdominal cavity, and peritoneal irritation due to entrapment of dissolved CO2 [1-7]. Intraperitoneal acidosis, mucosal ischemia and compression of the splanchnic nerve as a consequence of the pneumoperitoneum may also be relevant factors [8,9]. On the other hand, shoulder pain is related to phrenic nerve and diaphragm irrigation due to residual CO2 in the subdiaphragmatic space [7-9].

In addition to pain, CO2 insufflation and a concomitant steep head-down (Trendelenburg, TP) position in surgical procedure also cause an increase in intra-abdominal pressure, which unfavorably affect patients homeostasis, inducing a significant change in the respiratory and cardiovascular system, lessening perfusion in abdominal organs and blood flow in the inferior vena cava, and posing an increased risk of thrombotic disease [10,11].

Low-pressure pneumoperitoneum (LPP, 7-10 mmHg) is recommended to minimize the adverse side effects associated with SPP [12]. There are several reports on the safety of low CO2 pneumoperitoneum pressure (LPP) in gynecological laparoscopic procedures however their trials have some limitations due to the small sample size, performed in only short laparoscopic procedures, and inadequate to assess the surgical impression of visualization [13-16]. Thus, further studies are still required.

Therefore, the purpose of this randomized controlled trial (RCT) is to assess the effect of LPP versus SPP on metabolic response, postoperative pain scores, surgical field visualization.

Conditions

Gynecologic Surgery

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

Control

All laparoscopic surgical procedures were performed at 12 mmHg CO2 pressure throughout the surgery

Group Type: NO_INTERVENTION

No interventions assigned to this group

Study

All laparoscopic surgical procedures were performed at 8 mmHg CO2 pressure throughout the surgery

Group Type: EXPERIMENTAL

carbon dioxide

Intervention Type: OTHER

carbon dioxide insufflation pressure

Interventions

carbon dioxide

carbon dioxide insufflation pressure

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Women underwent a total laparoscopic hysterectomy with or without additional surgery, such as salpingo-oophorectomy, salpingectomy, or pelvic and/or para-aortic lymphadenectomy

Exclusion Criteria

• those who refused to give consent
• inability to understand the research questionnaire
• severe psychiatric or mental disorders
• American Society of Anesthesiologists (ASA) physical status classification > III
• conversion to laparotomy.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Erzincan Military Hospital

OTHER

Sponsor Role: lead

Responsible Party

Kemal GUNGORDUK

KG

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Mugla Sıtkı Kocman University Education and Research Hospital

Muğla, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

MUGLA-4

Identifier Type: -

Identifier Source: org_study_id