Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04221308
Other study ID # 23068423
Secondary ID
Status Completed
Phase
First received
Last updated
Start date January 1, 2018
Est. completion date December 15, 2019

Study information

Verified date January 2020
Source Derince Training and Research Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The authors aimed to detect inflammatory marker changes in two natural orifice hysterectomies: single-port laparoscopic hysterectomy (SLH) and vaginal hysterectomy (VH).

Between 2018 and 2019, data obtained from patients in the SLH and VH groups were reviewed retrospectively. The preoperative and postoperative hematocrit (HCT), hemoglobin (HB), white blood cell (WBC), platelet (PLR), and neutrophil-lymphocyte (NLR) ratios and values were compared as well as the demographic characteristics of the patients.


Recruitment information / eligibility

Status Completed
Enrollment 134
Est. completion date December 15, 2019
Est. primary completion date November 30, 2019
Accepts healthy volunteers No
Gender Female
Age group 45 Years to 60 Years
Eligibility Inclusion Criteria:

- hysterectomy requirement with any conditions in gynecologic diseases

Exclusion Criteria:

- patients with a chronic disease (e.g., hypertension, diabetes mellitus, and rheumatologic, nephrological, and hematological diseases)

- the presence of active infection

- using of corticosteroid, acetylsalicylic acid, or anticoagulant

- cystocele or rectocele repair with mesh

Study Design


Intervention

Device:
Single port laparoscopic systems
The first assistant handles the scope from the patient's right side. The second assistant, who is positioned between the legs of the patient, inserts a uterine manipulator (Rumi System; Cooper Surgical, CT). At the beginning of the surgery, a 1.5 to 2.5 cm vertical incision is made within the umbilicus using the open Hasson approach. After the bottom retractor ring of the wound retractor component of the Octo-Port is inverted (DalimSurgNet, Seoul, Korea), it is inserted through the incision deep in the peritoneum. Carbon dioxide is insufflated through the gas valve of the Octo-Port to maintain intra-abdominal pressure at 10 to 12 mm Hg. Through the 10 mm channels of the Octo-Port, a 10 mm, 30° rigid laparoscope is introduced. Rigid laparoscopic instruments are introduced through the 5 mm channels of the Octo-Port. The utero-ovarian ligament or infundibulopelvic ligament, uterine vessels, and uterine ligaments are transected by using the 5 mm LigaSure vessel sealer device

Locations

Country Name City State
Turkey Derince Training and Research Hospital Kocaeli

Sponsors (1)

Lead Sponsor Collaborator
Derince Training and Research Hospital

Country where clinical trial is conducted

Turkey, 

References & Publications (33)

AAGL Advancing Minimally Invasive Gynecology Worldwide. AAGL position statement: route of hysterectomy to treat benign uterine disease. J Minim Invasive Gynecol. 2011 Jan-Feb;18(1):1-3. doi: 10.1016/j.jmig.2010.10.001. Epub 2010 Nov 6. — View Citation

ACOG Committee Opinion No. 444: choosing the route of hysterectomy for benign disease. Obstet Gynecol. 2009 Nov;114(5):1156-8. doi: 10.1097/AOG.0b013e3181c33c72. — View Citation

Allendorf JD, Bessler M, Whelan RL, Trokel M, Laird DA, Terry MB, Treat MR. Postoperative immune function varies inversely with the degree of surgical trauma in a murine model. Surg Endosc. 1997 May;11(5):427-30. — View Citation

Choi YS, Shin KS, Choi J, Park JN, Oh YS, Rhee TE. Single-port access laparoscopy-assisted vaginal hysterectomy: our initial experiences with 100 cases. Minim Invasive Surg. 2012;2012:543627. doi: 10.1155/2012/543627. Epub 2012 Sep 4. — View Citation

Collet D, Vitale GC, Reynolds M, Klar E, Cheadle WG. Peritoneal host defenses are less impaired by laparoscopy than by open operation. Surg Endosc. 1995 Oct;9(10):1059-64. — View Citation

Cruickshank AM, Fraser WD, Burns HJ, Van Damme J, Shenkin A. Response of serum interleukin-6 in patients undergoing elective surgery of varying severity. Clin Sci (Lond). 1990 Aug;79(2):161-5. — View Citation

Dedden SJ, Geomini PMAJ, Huirne JAF, Bongers MY. Vaginal and Laparoscopic hysterectomy as an outpatient procedure: A systematic review. Eur J Obstet Gynecol Reprod Biol. 2017 Sep;216:212-223. doi: 10.1016/j.ejogrb.2017.07.015. Epub 2017 Jul 22. Review. — View Citation

Fader AN, Escobar PF. Laparoendoscopic single-site surgery (LESS) in gynecologic oncology: technique and initial report. Gynecol Oncol. 2009 Aug;114(2):157-61. doi: 10.1016/j.ygyno.2009.05.020. Epub 2009 May 28. — View Citation

Faist E, Kupper TS, Baker CC, Chaudry IH, Dwyer J, Baue AE. Depression of cellular immunity after major injury. Its association with posttraumatic complications and its reversal with immunomodulation. Arch Surg. 1986 Sep;121(9):1000-5. — View Citation

Fornara P, Doehn C, Seyfarth M, Jocham D. Why is urological laparoscopy minimally invasive? Eur Urol. 2000 Mar;37(3):241-50. — View Citation

Garry R. Health economics of hysterectomy. Best Pract Res Clin Obstet Gynaecol. 2005 Jun;19(3):451-65. Epub 2005 Mar 2. Review. — View Citation

Goolab BD. Vaginal hysterectomy and relative merits over abdominal and laparoscopically assisted hysterectomy. Best Pract Res Clin Obstet Gynaecol. 2013 Jun;27(3):393-413. doi: 10.1016/j.bpobgyn.2013.01.003. Epub 2013 Apr 18. — View Citation

Grace PA, Quereshi A, Coleman J, Keane R, McEntee G, Broe P, Osborne H, Bouchier-Hayes D. Reduced postoperative hospitalization after laparoscopic cholecystectomy. Br J Surg. 1991 Feb;78(2):160-2. — View Citation

Gupta A, Watson DI. Effect of laparoscopy on immune function. Br J Surg. 2001 Oct;88(10):1296-306. Review. — View Citation

Gynecol Surg. 2010; 7(2):143-148

Gynecol Surg. 2013; 10:117-122

Iwase M, Kondo G, Watanabe H, Takaoka S, Uchida M, Ohashi M, Nagumo M. Regulation of Fas-mediated apoptosis in neutrophils after surgery-induced acute inflammation. J Surg Res. 2006 Jul;134(1):114-23. Epub 2005 Dec 27. — View Citation

J Obstet Gynaecol. 2019; 26:1-5.

Lee YY, Kim TJ, Kim CJ, Kang H, Choi CH, Lee JW, Kim BG, Lee JH, Bae DS. Single-port access laparoscopic-assisted vaginal hysterectomy: a novel method with a wound retractor and a glove. J Minim Invasive Gynecol. 2009 Jul-Aug;16(4):450-3. doi: 10.1016/j.jmig.2009.03.022. Epub 2009 May 31. — View Citation

Lennard TW, Shenton BK, Borzotta A, Donnelly PK, White M, Gerrie LM, Proud G, Taylor RM. The influence of surgical operations on components of the human immune system. Br J Surg. 1985 Oct;72(10):771-6. — View Citation

Liliana M, Alessandro P, Giada C, Luca M. Single-port access laparoscopic hysterectomy: a new dimension of minimally invasive surgery. J Gynecol Endosc Surg. 2011 Jan;2(1):11-7. doi: 10.4103/0974-1216.85273. — View Citation

Malik E, Buchweitz O, Müller-Steinhardt M, Kressin P, Meyhöfer-Malik A, Diedrich K. Prospective evaluation of the systemic immune response following abdominal, vaginal, and laparoscopically assisted vaginal hysterectomy. Surg Endosc. 2001 May;15(5):463-6. Epub 2001 Mar 13. — View Citation

Nieboer TE, Hendriks JC, Bongers MY, Vierhout ME, Kluivers KB. Quality of life after laparoscopic and abdominal hysterectomy: a randomized controlled trial. Obstet Gynecol. 2012 Jan;119(1):85-91. doi: 10.1097/AOG.0b013e31823d3b00. — View Citation

Nieboer TE, Johnson N, Lethaby A, Tavender E, Curr E, Garry R, van Voorst S, Mol BW, Kluivers KB. Surgical approach to hysterectomy for benign gynaecological disease. Cochrane Database Syst Rev. 2009 Jul 8;(3):CD003677. doi: 10.1002/14651858.CD003677.pub4. Review. Update in: Cochrane Database Syst Rev. 2015;8:CD003677. — View Citation

Ogawa K, Hirai M, Katsube T, Murayama M, Hamaguchi K, Shimakawa T, Naritake Y, Hosokawa T, Kajiwara T. Suppression of cellular immunity by surgical stress. Surgery. 2000 Mar;127(3):329-36. Erratum in: Surgery 2000 Jun;127(6):613. — View Citation

Ramirez PT. Single-port laparoscopic surgery: is a single incision the next frontier in minimally invasive gynecologic surgery? Gynecol Oncol. 2009 Aug;114(2):143-4. doi: 10.1016/j.ygyno.2009.06.007. — View Citation

Romanelli JR, Earle DB. Single-port laparoscopic surgery: an overview. Surg Endosc. 2009 Jul;23(7):1419-27. doi: 10.1007/s00464-009-0463-x. Epub 2009 Apr 4. Review. — View Citation

Sandberg EM, la Chapelle CF, van den Tweel MM, Schoones JW, Jansen FW. Laparoendoscopic single-site surgery versus conventional laparoscopy for hysterectomy: a systematic review and meta-analysis. Arch Gynecol Obstet. 2017 May;295(5):1089-1103. doi: 10.1007/s00404-017-4323-y. Epub 2017 Mar 29. Review. — View Citation

Sietses C, Wiezer MJ, Eijsbouts QA, Beelen RH, van Leeuwen PA, von Blomberg BM, Meijer S, Cuesta MA. A prospective randomized study of the systemic immune response after laparoscopic and conventional Nissen fundoplication. Surgery. 1999 Jul;126(1):5-9. — View Citation

Sietses C, Wiezer MJ, Eijsbouts QA, van Leeuwen PA, Beelen RH, Meijer S, Cuesta MA. The influence of laparoscopic surgery on postoperative polymorphonuclear leukocyte function. Surg Endosc. 2000 Sep;14(9):812-6. — View Citation

Slade MS, Simmons RL, Yunis E, Greenberg LJ. Immunodepression after major surgery in normal patients. Surgery. 1975 Sep;78(3):363-72. — View Citation

Terzi H, Biler A, Turkay U, Kale A. A comparison of novel laparoscopic suturing techniques in single-port surgery. Minim Invasive Ther Allied Technol. 2019 Dec;28(6):338-343. doi: 10.1080/13645706.2019.1567554. Epub 2019 Feb 22. — View Citation

Yoon BS, Seong SJ, Kim IH, Song T, Kim ML, Kim MK. Operative outcomes of single-port-access laparoscopy-assisted vaginal hysterectomy compared with single-port-access total laparoscopic hysterectomy. Taiwan J Obstet Gynecol. 2014 Dec;53(4):486-9. doi: 10.1016/j.tjog.2013.07.003. — View Citation

* Note: There are 33 references in allClick here to view all references

Outcome

Type Measure Description Time frame Safety issue
Primary Changes in hematocrit levels Hematocrit (%) levels in the first 24 hours after single port laparoscopic or vaginal hysterectomies were compared. 1 day
Primary Changes in hemoglobin levels Hemoglobin levels in the first 24 hours after single port laparoscopic or vaginal hysterectomies were compared. 1 day
Primary Changes in white blood cell levels white blood cell (x103/mm3), in the first 24 hours after single port laparoscopic or vaginal hysterectomies were compared. 1 day
Primary Changes in neutrophil-lymphocyte and platelet-lymphocyte ratio neutrophil-lymphocyte and platelet-lymphocyte ratio in the first 24 hours after single port laparoscopic or vaginal hysterectomies were compared. 1 day
See also
  Status Clinical Trial Phase
Completed NCT03995979 - Inflammation and Protein Restriction N/A
Completed NCT03255187 - Effect of Dietary Supplemental Fish Oil in Alleviating Health Hazards Associated With Air Pollution N/A
Completed NCT04507867 - Effect of a NSS to Reduce Complications in Patients With Covid-19 and Comorbidities in Stage III N/A
Completed NCT03577223 - Egg Effects on the Immunomodulatory Properties of HDL N/A
Completed NCT04383561 - Relationship Between LRG and Periodontal Disease N/A
Active, not recruiting NCT03622632 - Pilot Study to Measure Uric Acid in Traumatized Patients: Determinants and Prognostic Association
Completed NCT06216015 - Exercise Training and Kidney Transplantation N/A
Completed NCT04856748 - Nomogram to Diagnose Prostatic Inflammation (PIN) in Men With Lower Urinary Tract Symptoms
Completed NCT05529693 - Efficacy of a Probiotic Strain on Level of Markers of Inflammation in an Elderly Population N/A
Recruiting NCT05670301 - Flemish Joint Effort for Biomarker pRofiling in Inflammatory Systemic Diseases N/A
Recruiting NCT05415397 - Treating Immuno-metabolic Depression With Anti-inflammatory Drugs Phase 3
Recruiting NCT04543877 - WHNRC (Western Human Nutrition Research Center) Fiber Intervention Study Early Phase 1
Recruiting NCT05775731 - Markers of Inflammation and of the Pro-thrombotic State in Hospital Shift and Day Workers
Completed NCT03859934 - Metabolic Effects of Melatonin Treatment Phase 1
Completed NCT03429920 - Effect of Fermented Soy Based Product on Cardiometabolic Risk Factors N/A
Completed NCT06065241 - Quantifiably Determine if the Botanical Formulation, LLP-01, Has a Significant Clinical Effect on Proteomic Inflammatory Biomarkers and Epigenetic Changes in Healthy, Older Individuals. N/A
Completed NCT05864352 - The Role of Dietary Titanium Dioxide on the Human Gut Microbiome and Health
Completed NCT03318731 - Efficacy and Safety of Fenugreek Extract on Markers of Muscle Damage and Inflammation in Untrained Males N/A
Not yet recruiting NCT06134076 - Comparing Effects of Fermented and Unfermented Pulses and Gut Microbiota N/A
Not yet recruiting NCT06159543 - The Effects of Fresh Mango Consumption on Cardiometabolic Outcomes in Free-living Individuals With Prediabetes N/A