Veress Entry With/Without Concomitant CO2
| Status: | Completed |
|---|---|
| Conditions: | Hospital, Hospital, Women's Studies |
| Therapuetic Areas: | Other, Reproductive |
| Healthy: | No |
| Age Range: | 18 - 70 |
| Updated: | 4/17/2018 |
| Start Date: | August 2016 |
| End Date: | March 10, 2018 |
Laparoscopic Entry Technique With a Veress Needle Insertion With and Without Concomitant CO2 Insufflation - Does it Matter?
Purpose: The primary objective is to compare the time required for adequate intraperitoneal
insufflation (from skin incision to reaching intraperitoneal pressure of 15 mmHg). Also the
number of attempts needed before successful entry is achieved. The secondary objectives will
evaluate rates of secondary outcomes measures such as; failed entry, extra peritoneal
insufflation, vascular injury, visceral injury, gas embolism, solid organ injury, and omental
injury between the two techniques.
Study design: prospective randomized control trial
Hypothesis: The investigators hypothesize that participant's undergoing laparoscopic surgery
for benign Gynecologic indications at TGH who undergo laparoscopic entry technique of Veress
needle entry with concomitant CO2 insufflation will require less time to achieve a 15 mmHg of
intraperitoneal pressure as opposed to Veress needle entry with subsequent CO2 insufflation,
and will require less number of attempts to achieve successful entry.
insufflation (from skin incision to reaching intraperitoneal pressure of 15 mmHg). Also the
number of attempts needed before successful entry is achieved. The secondary objectives will
evaluate rates of secondary outcomes measures such as; failed entry, extra peritoneal
insufflation, vascular injury, visceral injury, gas embolism, solid organ injury, and omental
injury between the two techniques.
Study design: prospective randomized control trial
Hypothesis: The investigators hypothesize that participant's undergoing laparoscopic surgery
for benign Gynecologic indications at TGH who undergo laparoscopic entry technique of Veress
needle entry with concomitant CO2 insufflation will require less time to achieve a 15 mmHg of
intraperitoneal pressure as opposed to Veress needle entry with subsequent CO2 insufflation,
and will require less number of attempts to achieve successful entry.
Subject Recruitment and Consent:
All female patients age 18-70 scheduled for benign gynecologic laparoscopic surgery at TGH by
a participating attending surgeon will be recruited. Each participant will be educated about
the study; its objectives, potential benefits and risks, and the research team will obtain
informed consent. Plan to enroll 90 participants.
Materials and Methods:
This will be a randomized control trial in which participants will be randomly assigned to
have laparoscopic entry with Veress needle connected to CO2 tubing for concomitant
insufflation versus Veress needle entry with subsequent connection to CO2 tubing for
insufflation. The investigators will inform the patients about the two entry techniques
during the pre-operative office visit. Participants will be consented to participate in the
study prior to the surgery by the study research coordinators during their pre-operative
visit. Patients who do not consent for the study will still undergo the scheduled procedure
with standard entry technique as clinically indicated by their provider. Randomization will
occur in the operating room just before the surgery starts. The healthcare provider
performing the procedure will open the next sequentially numbered envelope, within which
there will be a piece of paper indicating the entry technique to be performed. This will then
be recorded in the study log. The study log will include enrolled participants, assigned
study number which will range from 001 to the minimum number of participants required for the
study as indicated by sample size calculation (see below). The participant will be positioned
in the dorsal lithotomy position and prepped and draped in the standard fashion. Preoperative
antibiotics will be provided as per standard indication for the procedure. For the group of
participants who will be randomized to concomitant CO2 insufflation; the Veress will be
connected to the CO2 tubing, and a skin incision will be made with the scalpel, followed by
starting the CO2 gas insufflation and insertion of the Veress needle. If the opening pressure
is less than or equal to 10 mmHg, the process of insufflation will be allowed to continue. In
case of a higher opening pressure, the Veress will be withdrawn and reinserted up to 3 times.
A failed entry will be called if the peritoneal cavity cannot be insufflated after 3
attempts. For the other group of patients who will be randomized to subsequent CO2
insufflation; the Veress needle will be connected to the CO2 tubing, and a skin incision will
be made with the scalpel, followed by insertion of the Veress needle. The gas insufflation
will be started and the opening pressure will be noted. If the opening pressure is less than
or equal to 10 mmHg, the process of insufflation will be allowed to continue. In case of a
higher opening pressure, the Veress needle will be withdrawn and reinserted up to 3 times.
Each time the needle is to reinserted, the CO2 insufflator will be switched off until the
location of the Veress needle is felt to be adequate. The time will be recorded from incision
to the time it takes to achieve intraperitoneal pressure of 15 mmHg. In addition to the above
primary and secondary outcomes of the study, participant demographic information, procedure
specific variables and outcomes will be collected and recorded in the study log (See data
collection sheet). Common laparoscopic complications will also be recorded, including the
following:
- Vascular injury: any tear or injury to any intraabdominal blood vessels.
- Visceral injury: any serosal (superficial) or full thickness (deep) injury to the small
or the large bowel.
- Gas embolism: entrapment of carbon dioxide in an injured vein, artery or solid organ,
and results in blockage of the right ventricle (RV) or pulmonary artery
- Solid organ injury: any injury of a solid abdominal or pelvic organ including but not
limited to, liver, spleen or the uterus.
- Failed entry: failure to establish pneumoperitoneum after 3 attempts of Veress
insufflation.
- Extraperitoneal insufflation: insufflating the preperitoneal space with carbon dioxide.
- Omental injury: any injury to the greater omentum that results in bleeding of omental
insufflation.
Sample size: 90 patients will be recruited based on the sample size calculations already
performed.
All female patients age 18-70 scheduled for benign gynecologic laparoscopic surgery at TGH by
a participating attending surgeon will be recruited. Each participant will be educated about
the study; its objectives, potential benefits and risks, and the research team will obtain
informed consent. Plan to enroll 90 participants.
Materials and Methods:
This will be a randomized control trial in which participants will be randomly assigned to
have laparoscopic entry with Veress needle connected to CO2 tubing for concomitant
insufflation versus Veress needle entry with subsequent connection to CO2 tubing for
insufflation. The investigators will inform the patients about the two entry techniques
during the pre-operative office visit. Participants will be consented to participate in the
study prior to the surgery by the study research coordinators during their pre-operative
visit. Patients who do not consent for the study will still undergo the scheduled procedure
with standard entry technique as clinically indicated by their provider. Randomization will
occur in the operating room just before the surgery starts. The healthcare provider
performing the procedure will open the next sequentially numbered envelope, within which
there will be a piece of paper indicating the entry technique to be performed. This will then
be recorded in the study log. The study log will include enrolled participants, assigned
study number which will range from 001 to the minimum number of participants required for the
study as indicated by sample size calculation (see below). The participant will be positioned
in the dorsal lithotomy position and prepped and draped in the standard fashion. Preoperative
antibiotics will be provided as per standard indication for the procedure. For the group of
participants who will be randomized to concomitant CO2 insufflation; the Veress will be
connected to the CO2 tubing, and a skin incision will be made with the scalpel, followed by
starting the CO2 gas insufflation and insertion of the Veress needle. If the opening pressure
is less than or equal to 10 mmHg, the process of insufflation will be allowed to continue. In
case of a higher opening pressure, the Veress will be withdrawn and reinserted up to 3 times.
A failed entry will be called if the peritoneal cavity cannot be insufflated after 3
attempts. For the other group of patients who will be randomized to subsequent CO2
insufflation; the Veress needle will be connected to the CO2 tubing, and a skin incision will
be made with the scalpel, followed by insertion of the Veress needle. The gas insufflation
will be started and the opening pressure will be noted. If the opening pressure is less than
or equal to 10 mmHg, the process of insufflation will be allowed to continue. In case of a
higher opening pressure, the Veress needle will be withdrawn and reinserted up to 3 times.
Each time the needle is to reinserted, the CO2 insufflator will be switched off until the
location of the Veress needle is felt to be adequate. The time will be recorded from incision
to the time it takes to achieve intraperitoneal pressure of 15 mmHg. In addition to the above
primary and secondary outcomes of the study, participant demographic information, procedure
specific variables and outcomes will be collected and recorded in the study log (See data
collection sheet). Common laparoscopic complications will also be recorded, including the
following:
- Vascular injury: any tear or injury to any intraabdominal blood vessels.
- Visceral injury: any serosal (superficial) or full thickness (deep) injury to the small
or the large bowel.
- Gas embolism: entrapment of carbon dioxide in an injured vein, artery or solid organ,
and results in blockage of the right ventricle (RV) or pulmonary artery
- Solid organ injury: any injury of a solid abdominal or pelvic organ including but not
limited to, liver, spleen or the uterus.
- Failed entry: failure to establish pneumoperitoneum after 3 attempts of Veress
insufflation.
- Extraperitoneal insufflation: insufflating the preperitoneal space with carbon dioxide.
- Omental injury: any injury to the greater omentum that results in bleeding of omental
insufflation.
Sample size: 90 patients will be recruited based on the sample size calculations already
performed.
Inclusion Criteria:
- All female patients within the ages of 18-70 presenting to TGH for benign gynecologic
laparoscopic surgery performed by the study investigators. The following surgeries
will be considered as part of the study:
- Diagnostic laparoscopy
- Laparoscopic adnexal surgery
- Laparoscopic hysterectomy
- Laparoscopic myomectomy
- Robotic assisted hysterectomy
- Robotic assisted myomectomy
Exclusion Criteria:
- Patients unable to provide informed consent
- Previous midline laparotomy
- 3 or more previous cesarean sections through a Pfannenstiel incision
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