Transumbilical Versus Lateral Transabdominal Removal of Benign Adnexal Masses Via Laparoscopy

Postoperative Pain Clinical Trial

Official title:

Transumbilical Versus Lateral Transabdominal Removal of Benign Adnexal Masses Via Laparoscopy, a Randomized Trial

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02704663
• Other study ID #: 98/13/03/03/2014
• Status: Active, not recruiting
• Phase: N/A
• First received: January 18, 2016
• Last updated: March 9, 2016
• Start date: November 2014
• Est. completion date: May 2016

Study information

• Verified date: March 2016
• Source: Helsinki University Central Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Finland: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

In cases of benign adnexal mass laparoscopic surgery, women were randomized to two groups: transumbilical vs. transabdominal removal. Need for pain medication, postoperative pain and patients´ satisfaction were assessed between the groups, as well as surgeons´ opinions and costs.

Description:

Women assigned to laparoscopic surgery for removal of a benign adnexal mass were randomly divided into two groups as regards surgery: a transumbilical (TU) group (n=21) and a transabdominal (TA) group (n=21). General anesthesia and use of local anesthetics were standardized. Visual analog scale (VAS) scores for pain and side effects (nausea/vomiting) and the amount of postoperative analgesic used were recorded for 24 hours. Investigators also investigated the expenses related to endobags and trocars. Further, peri- and postoperative complications were recorded. Investigators inquired about patient satisfaction as well as the surgeons' opinions of the alternative methods available.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 42
• Est. completion date: May 2016
• Est. primary completion date: May 2016
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years to 60 Years

Eligibility

Inclusion Criteria:

• The criteria for inclusion were scheduled laparoscopy for oophorectomy, salpingo-oophorectomy or cyst enucleation.

Exclusion Criteria:

• The exclusion criteria were contraindications to any of the forms of medication used in the study (oxycodone, ketoprofen, paracetamol),

• language difficulties (inability to understand and speak Finnish or Swedish)

• and suspicion of malignancy.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Pain, Postoperative
• Postoperative Pain

Intervention

Procedure:
• Transumbilical removal of specimen via laparoscopy
Transumbilical removal of a benign adnexal mass from the abdominal cavity in laparoscopy
• Lateral transabdominal removal of specimen via laparoscopy
Lateral transabdominal removal of a benign adnexal mass from the abdominal cavity in laparoscopy

Locations

Country	Name	City	State
Finland	Kätilöopisto Maternity Hospital, Helsinki University hospital	Helsinki

Sponsors (1)

Lead Sponsor	Collaborator
Helsinki University Central Hospital

Country where clinical trial is conducted

Finland, 

References & Publications (15)

Akdemir A, Ergenoglu AM, Akman L, Yeniel AÖ, Sendag F, Oztekin MK. A novel technique for laparoscopic removal of the fallopian tube after ectopic pregnancy via transabdominal or transumbilical port using homemade bag: A randomized trial. J Res Med Sci. 2013 Sep;18(9):777-81. — View Citation

Alessandri F, Lijoi D, Mistrangelo E, Nicoletti A, Ragni N. Effect of presurgical local infiltration of levobupivacaine in the surgical field on postsurgical wound pain in laparoscopic gynecological surgery. Acta Obstet Gynecol Scand. 2006;85(7):844-9. — View Citation

Chou LY, Sheu BC, Chang DY, Huang SC, Chen SY, Hsu WC, Chang WC. Comparison between transumbilical and transabdominal ports for the laparoscopic retrieval of benign adnexal masses: a randomized trial. Eur J Obstet Gynecol Reprod Biol. 2010 Dec;153(2):198-202. doi: 10.1016/j.ejogrb.2010.07.029. Epub 2010 Aug 11. — View Citation

Ghezzi F, Cromi A, Uccella S, Bogani G, Serati M, Bolis P. Transumbilical versus transvaginal retrieval of surgical specimens at laparoscopy: a randomized trial. Am J Obstet Gynecol. 2012 Aug;207(2):112.e1-6. doi: 10.1016/j.ajog.2012.05.016. Epub 2012 May 23. — View Citation

Ghezzi F, Cromi A, Uccella S, Siesto G, Bergamini V, Bolis P. Transumbilical surgical specimen retrieval: a viable refinement of laparoscopic surgery for pelvic masses. BJOG. 2008 Sep;115(10):1316-20. doi: 10.1111/j.1471-0528.2008.01802.x. — View Citation

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. — View Citation

Jokela R, Ahonen J, Tallgren M, Haanpää M, Korttila K. A randomized controlled trial of perioperative administration of pregabalin for pain after laparoscopic hysterectomy. Pain. 2008 Jan;134(1-2):106-12. Epub 2007 May 15. — View Citation

Jokela R, Ahonen J, Tallgren M, Haanpää M, Korttila K. Premedication with pregabalin 75 or 150 mg with ibuprofen to control pain after day-case gynaecological laparoscopic surgery. Br J Anaesth. 2008 Jun;100(6):834-40. doi: 10.1093/bja/aen098. Epub 2008 Apr 29. — View Citation

Kadar N, Reich H, Liu CY, Manko GF, Gimpelson R. Incisional hernias after major laparoscopic gynecologic procedures. Am J Obstet Gynecol. 1993 May;168(5):1493-5. — View Citation

Karthik S, Augustine AJ, Shibumon MM, Pai MV. Analysis of laparoscopic port site complications: A descriptive study. J Minim Access Surg. 2013 Apr;9(2):59-64. doi: 10.4103/0972-9941.110964. — View Citation

Marks JL, Ata B, Tulandi T. Systematic review and metaanalysis of intraperitoneal instillation of local anesthetics for reduction of pain after gynecologic laparoscopy. J Minim Invasive Gynecol. 2012 Sep-Oct;19(5):545-53. doi: 10.1016/j.jmig.2012.04.002. Epub 2012 Jul 3. Review. — View Citation

Nilsson L, Wodlin NB, Kjølhede P. Risk factors for postoperative complications after fast-track abdominal hysterectomy. Aust N Z J Obstet Gynaecol. 2012 Apr;52(2):113-20. doi: 10.1111/j.1479-828X.2011.01395.x. Epub 2012 Jan 8. — View Citation

Wodlin NB, Nilsson L, Kjølhede P. Health-related quality of life and postoperative recovery in fast-track hysterectomy. Acta Obstet Gynecol Scand. 2011 Apr;90(4):362-8. doi: 10.1111/j.1600-0412.2010.01058.x. Epub 2011 Feb 18. — View Citation

Wodlin NB, Nilsson L. The development of fast-track principles in gynecological surgery. Acta Obstet Gynecol Scand. 2013 Jan;92(1):17-27. doi: 10.1111/j.1600-0412.2012.01525.x. Epub 2012 Nov 1. Review. — View Citation

Yamamoto M, Minikel L, Zaritsky E. Laparoscopic 5-mm trocar site herniation and literature review. JSLS. 2011 Jan-Mar;15(1):122-6. doi: 10.4293/108680811X13022985131697. Review. — View Citation

* Note: There are 15 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The use of analgesics for postoperative pain	The total amount of analgesics used measured by use of Oxycodone (mg)	Change in 24 hours after surgery	No
Secondary	Complications	Frequency of complications. Values are given as n (%) and eventual complications are specified	The first six months after the surgical intervention	No
Secondary	Nausea	Nausea after the procedure: Visual Analog Score (VAS) for nausea, to measure quality of nausea. 10-point VAS score for nausea [(0-10), 0 indicating no nausea and 10 indicating unbearable nausea. at 1, 3, 6, 12 and 24 h (hour) after surgery. (Units on a Scale; 0-10)	Change in 24 hours after surgery	No
Secondary	Vomiting	Vomiting after the procedure: Visual Analog Score (VAS) for vomiting to measure quality of vomiting. 10-point VAS score for vomiting [(0-10), 0 indicating no vomiting and 10 indicating unbearable vomiting] at 1, 3, 6, 12 and 24 h (hour) after surgery. (Units on a Scale; 0-10)	Change in 24 hours after surgery	No
Secondary	Length of hospital stay in hours	Length of hospital stay measured from the end of the operation until discharge (hours)	Up to one week	No
Secondary	Quality of life	A questionnaire six months after operation concerning wellbeing outcome after six months (% of respondents in the group)	At baseline and 6 months after the surgery	No
Secondary	Cosmetic outcome	A questionnaire six months after operation concerning cosmetic outcome after six months (% of respondents in the group)	At baseline and 6 months after the surgery	No
Secondary	Costs	Calculating the comparative direct costs of both techniques. The cost of equipment used in the surgical intervention. (euros)	During the surgery	No
Secondary	Surgeon perception of both techniques	A questionnaire one month after operation of opinion of surgeons on preferred route of specimen removal (% of respondents in the group)	After one month after the operation	No
Secondary	Length of need of postoperative pain medication	A questionnaire of pain medication needed postoperatively. (Days)	Change in one month after surgery	No
Secondary	Postoperative pain scores	Visual Analog Score (VAS) for pain to measure quality of pain. 10-point VAS score for pain [(0-10), 0 indicating no pain and 10 indicating unbearable pain] at 1, 3, 6, 12 and 24 h (hour) after surgery (Units on a Scale; 0-10)	Change in 24 hours after surgery	No