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This study aims to investigate the effect of two peritoneal entry techniques on intraoperative and post-operative outcomes among patients undergoing laparoscopic surgery with a minimally invasive gynecologic surgeon. Patients will be randomized to either blunt fascial or veress needle peritoneal entry. Insufflation times, failed entries, complications and post-operative pain scores will be collected.
The investigators hypothesize that the blunt entry technique will be associated with shorter insufflation times and similar intraoperative and postoperative outcomes compared with the veress needle entry technique.
Primary Objective: To evaluate the insufflation times and success upon peritoneal entry according to peritoneal entry technique.
Secondary Objectives: To evaluate the surgical outcomes and patients pain scores according to peritoneal entry technique.
This will be a single-center, single-blinded randomized controlled trial evaluating the impact of peritoneal entry technique on insufflation times, entry failure, post-operative pain and surgical outcomes among patients undergoing laparoscopic gynecologic surgery. The investigators hypothesize that the blunt fascial entry technique will be associated with shorter insufflation times with no effect on other surgical outcomes. The study will include 2 groups corresponding to the entry techniques: blunt facial entry and Veress needle entry. Participants will be 1:1 allocated to each technique by block randomization.
Blunt fascial entry technique description: a 5 mm incision is made in the umbilicus. Next, a curved Kelly forceps is used to open the fascia, and, if possible, the peritoneum. The Kelly forceps are then used to expand the opening to a 10 mm diameter. A 5 mm trocar is placed into the fascial hole and used to quickly insufflate the abdomen to 15 mm Hg. Once the abdomen is fully insufflated, a 10 mm trocar is placed using optical guidance.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Blunt fascial entry | Experimental | The blunt fascial entry technique will be used for patients in this arm |
|
| Veress needle entry technique | Active Comparator | The Veress needle entry technique will be used for patients in this arm |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Blunt fascial abdominal entry | Procedure | Blunt fascial entry technique description: a 5 mm incision is made in the umbilicus. Next, a curved Kelly forceps is used to open the fascia, and, if possible, the peritoneum. The Kelly forceps are then used to expand the opening to a 10 mm diameter. A 5 mm trocar is placed into the fascial hole and used to quickly insufflate the abdomen to 15 mm Hg. Once the abdomen is fully insufflated, a 10 mm trocar is placed using optical guidance. |
| Measure | Description | Time Frame |
|---|---|---|
| Insufflation time | The time it takes to insufflate the abdominal cavity to 15 mm Hg. | Intraoperative |
| Success upon peritoneal entry | Successful abdominal entry in the first trial | Intraoperative |
| Measure | Description | Time Frame |
|---|---|---|
| Intraoperative complications | - Intraoperative complications upon peritoneal entry | Intraoperative |
| Postoperative complications | Any postoperative complications |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Raanan Meyer, MD | Contact | 3104234073 | Raanan.Meyer@cshs.org | |
| Kacey Hamilton | Contact | 3104234073 |
| Name | Affiliation | Role |
|---|---|---|
| Raanan Meyer, MD | Cedars-Sinai Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cedars Sinai Medical Center | Recruiting | Los Angeles | California | 90048 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30657163 | Background | Ahmad G, Baker J, Finnerty J, Phillips K, Watson A. Laparoscopic entry techniques. Cochrane Database Syst Rev. 2019 Jan 18;1(1):CD006583. doi: 10.1002/14651858.CD006583.pub5. | |
| 9166204 | Background | Jansen FW, Kapiteyn K, Trimbos-Kemper T, Hermans J, Trimbos JB. Complications of laparoscopy: a prospective multicentre observational study. Br J Obstet Gynaecol. 1997 May;104(5):595-600. doi: 10.1111/j.1471-0528.1997.tb11539.x. |
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| ID | Term |
|---|---|
| D010149 | Pain, Postoperative |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
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|
| Veress needle abdominal entry | Procedure | Veress needle abdominal entry technique description: a 5 mm incision is made in the umbilicus. Next, a Veress needle is used to enter the peritoneal cavity and inflate the abdomen to 15 mm Hg. Once the abdomen is fully insufflated, a 10 mm trocar is placed using optical guidance. |
|
| Postoperative period within 30 days of surgery |
| Patients pain scores |
| Day of surgery, postoperatively and before discharge |
| Analgesics use | - Total analgesic requirements in PACU | Day of surgery, postoperatively and before discharge |
| Length of hospital stay | - Length of stay- from arrival to PACU to discharge home) | Day of surgery, postoperatively and before discharge. In rare cases, hospital stay will be longer than one day. |
| 19661756 | Background | Makai G, Isaacson K. Complications of gynecologic laparoscopy. Clin Obstet Gynecol. 2009 Sep;52(3):401-11. doi: 10.1097/GRF.0b013e3181b0c080. |
| 12230057 | Background | Molloy D, Kaloo PD, Cooper M, Nguyen TV. Laparoscopic entry: a literature review and analysis of techniques and complications of primary port entry. Aust N Z J Obstet Gynaecol. 2002 Aug;42(3):246-54. doi: 10.1111/j.0004-8666.2002.00246.x. |
| 19263124 | Background | Azevedo JL, Azevedo OC, Miyahira SA, Miguel GP, Becker OM Jr, Hypolito OH, Machado AC, Cardia W, Yamaguchi GA, Godinho L, Freire D, Almeida CE, Moreira CH, Freire DF. Injuries caused by Veress needle insertion for creation of pneumoperitoneum: a systematic literature review. Surg Endosc. 2009 Jul;23(7):1428-32. doi: 10.1007/s00464-009-0383-9. Epub 2009 Mar 5. |
| 22423957 | Background | Jiang X, Anderson C, Schnatz PF. The safety of direct trocar versus Veress needle for laparoscopic entry: a meta-analysis of randomized clinical trials. J Laparoendosc Adv Surg Tech A. 2012 May;22(4):362-70. doi: 10.1089/lap.2011.0432. Epub 2012 Mar 16. |
| 22442503 | Background | Krishnakumar S, Tambe P. Entry complications in laparoscopic surgery. J Gynecol Endosc Surg. 2009 Jan;1(1):4-11. doi: 10.4103/0974-1216.51902. |
| 16291435 | Background | Kendrick DB, Strout TD. The minimum clinically significant difference in patient-assigned numeric scores for pain. Am J Emerg Med. 2005 Nov;23(7):828-32. doi: 10.1016/j.ajem.2005.07.009. |
| 14499431 | Background | Cepeda MS, Africano JM, Polo R, Alcala R, Carr DB. What decline in pain intensity is meaningful to patients with acute pain? Pain. 2003 Sep;105(1-2):151-7. doi: 10.1016/s0304-3959(03)00176-3. |
| 32572753 | Background | Foley CE, Ryan E, Huang JQ. Less is more: clinical impact of decreasing pneumoperitoneum pressures during robotic surgery. J Robot Surg. 2021 Apr;15(2):299-307. doi: 10.1007/s11701-020-01104-4. Epub 2020 Jun 22. |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |