NCT01526655 is a NA clinical trial of Abdominal total hysterectomy in Endometrial Cancer, sponsored by University Hospital, Linkoeping.

Who is sponsoring NCT01526655?

NCT01526655 is sponsored by University Hospital, Linkoeping.

What drugs are being tested in NCT01526655?

Interventions in NCT01526655: Abdominal total hysterectomy, Robot assisted laparoscopic hysterectomy.

What condition does NCT01526655 study?

NCT01526655 studies Endometrial Cancer.

Is NCT01526655 still recruiting?

NCT01526655 is currently completed. Last updated 18 April 2024.

Are results published for NCT01526655?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2024-04-18 · How we verify

NCT01526655

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Robot Assisted Laparoscopic Hysterectomy vs. Abdominal Hysterectomy in Endometrial Cancer

Completed NA Results posted Last updated 18 April 2024

What this trial tests

NA trial testing Abdominal total hysterectomy in Endometrial Cancer in 50 participants. Completed in 27 July 2016.

Timeline

25 January 2012

Primary endpoint
27 July 2016

27 July 2016

Quick facts

Lead sponsor	University Hospital, Linkoeping
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	50
Start date	25 January 2012
Primary completion	27 July 2016
Estimated completion	27 July 2016
Sites	2 locations across Sweden

Drugs / interventions tested

Abdominal total hysterectomy
Robot assisted laparoscopic hysterectomy

Conditions studied

Endometrial Cancer — all drugs for Endometrial Cancer →

Sponsor

University Hospital, Linkoeping

Who can join

18 and older, female only, with Endometrial Cancer. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Health Related Quality of Life (HRQoL) Primary · Days 0, 1, 2, 3, 4, 5, 6, 7, 14, 21, 28, 35, 42

Quality of life measured by means of the EuroQol form (EQ-5D). The EQ-5D form was completed daily during the first eight days after surgery, then once weekly for additional six weeks. The health state index has a possible range from 0 to 1 with a higher score meaning a better quality of life.

EQ-5D Day 0

Group	Value	95% CI
Robotic Hysterectomy	0.34	± 0.40
Abdominal Hysterectomy	0.30	± 0.53

EQ-5D Day 1

Group	Value	95% CI
Robotic Hysterectomy	0.66	± 0.24
Abdominal Hysterectomy	0.48	± 0.40

EQ-5D Day 2

Group	Value	95% CI
Robotic Hysterectomy	0.74	± 0.19
Abdominal Hysterectomy	0.56	± 0.31

EQ-5D Day 3

Group	Value	95% CI
Robotic Hysterectomy	0.73	± 0.19
Abdominal Hysterectomy	0.59	± 0.28

EQ-5D Day 4

Group	Value	95% CI
Robotic Hysterectomy	0.77	± 0.19
Abdominal Hysterectomy	0.63	± 0.30

EQ-5D Day 5

Group	Value	95% CI
Robotic Hysterectomy	0.83	± 0.18
Abdominal Hysterectomy	0.64	± 0.31

EQ-5D Day 6

Group	Value	95% CI
Robotic Hysterectomy	0.84	± 0.17
Abdominal Hysterectomy	0.67	± 0.25

EQ-5D Day 7

Group	Value	95% CI
Robotic Hysterectomy	0.83	± 0.22
Abdominal Hysterectomy	0.66	± 0.29

Changes in Biomarkers for Tissue Damage (C-reactive Protein (hsCRP)) Secondary · One week and just before surgery. Two, 24 and 48 hours postoperatively. One and six weeks after surgery.

The biomarker was measured on seven occasions. Time 1: one week before surgery. Time 2: just before surgery. Time 3: two hours postoperatively. Time 4: 24 hours postoperatively. Time 5: 48 hours postoperatively. Time 6: one week after surgery. Time 7: six weeks after surgery.

hsCRP time 1

Group	Value	95% CI
Robotic Hysterectomy	2.5	± 2.1
Abdominal Hysterectomy	6.0	± 17.0

hsCRP time 2

Group	Value	95% CI
Robotic Hysterectomy	2.7	± 2.6
Abdominal Hysterectomy	4.7	± 11.4

hsCRP time 3

Group	Value	95% CI
Robotic Hysterectomy	2.3	± 2.3
Abdominal Hysterectomy	3.5	± 6.7

hsCRP time 4

Group	Value	95% CI
Robotic Hysterectomy	29.0	± 29.4
Abdominal Hysterectomy	52.3	± 27.0

hsCRP time 5

Group	Value	95% CI
Robotic Hysterectomy	46.3	± 49.8
Abdominal Hysterectomy	75.4	± 43.7

hsCRP time 6

Group	Value	95% CI
Robotic Hysterectomy	10.5	± 8.6
Abdominal Hysterectomy	9.3	± 8.6

hsCRP time 7

Group	Value	95% CI
Robotic Hysterectomy	2.9	± 2.6
Abdominal Hysterectomy	1.9	± 1.5

Changes in Biomarkers for Tissue Damage (White Blood Cells (WBC)) Secondary · One week and just before surgery. Two, 24 and 48 hours postoperatively. One and six weeks after surgery.

WBC time 1

Group	Value	95% CI
Robotic Hysterectomy	6.7	± 1.7
Abdominal Hysterectomy	7.7	± 2.1

WBC time 2

Group	Value	95% CI
Robotic Hysterectomy	6.2	± 1.7
Abdominal Hysterectomy	6.6	± 1.7

WBC time 3

Group	Value	95% CI
Robotic Hysterectomy	6.8	± 3.0
Abdominal Hysterectomy	11.4	± 3.7

WBC time 4

Group	Value	95% CI
Robotic Hysterectomy	9.4	± 3.3
Abdominal Hysterectomy	10.1	± 2.8

WBC time 5

Group	Value	95% CI
Robotic Hysterectomy	7.2	± 2.3
Abdominal Hysterectomy	9.2	± 2.3

WBC time 6

Group	Value	95% CI
Robotic Hysterectomy	7.2	± 2.0
Abdominal Hysterectomy	7.6	± 2.0

WBC time 7

Group	Value	95% CI
Robotic Hysterectomy	6.5	± 1.5
Abdominal Hysterectomy	6.8	± 1.6

Changes in Biomarkers for Tissue Damage (Interleukin 6 (IL-6)) Secondary · One week and just before surgery. Two, 24 and 48 hours postoperatively. One and six weeks after surgery.

IL-6 time 1

Group	Value	95% CI
Robotic Hysterectomy	15.0	± 29.8
Abdominal Hysterectomy	10.9	± 19.0

IL-6 time 2

Group	Value	95% CI
Robotic Hysterectomy	15.7	± 29.0
Abdominal Hysterectomy	9.6	± 13.8

IL-6 time 3

Group	Value	95% CI
Robotic Hysterectomy	21.0	± 28.7
Abdominal Hysterectomy	47.6	± 24.5

IL-6 time 4

Group	Value	95% CI
Robotic Hysterectomy	28.0	± 31.0
Abdominal Hysterectomy	37.9	± 19.0

IL-6 time 5

Group	Value	95% CI
Robotic Hysterectomy	15.3	± 21.8
Abdominal Hysterectomy	17.3	± 9.4

IL-6 time 6

Group	Value	95% CI
Robotic Hysterectomy	18.4	± 31.2
Abdominal Hysterectomy	10.0	± 12.1

IL-6 time 7

Group	Value	95% CI
Robotic Hysterectomy	13.1	± 25.7
Abdominal Hysterectomy	12.2	± 28.8

Changes in Biomarkers for Tissue Damage (Creatin Kinase (CK)) Secondary · One week and just before surgery. Two, 24 and 48 hours postoperatively. One and six weeks after surgery.

CK time 1

Group	Value	95% CI
Robotic Hysterectomy	1.8	± 1.1
Abdominal Hysterectomy	1.6	± 1.1

CK time 2

Group	Value	95% CI
Robotic Hysterectomy	1.9	± 1.1
Abdominal Hysterectomy	1.6	± 1.0

CK time 3

Group	Value	95% CI
Robotic Hysterectomy	1.5	± 0.9
Abdominal Hysterectomy	2.5	± 1.0

CK time 4

Group	Value	95% CI
Robotic Hysterectomy	3.3	± 2.5
Abdominal Hysterectomy	6.2	± 4.9

CK time 5

Group	Value	95% CI
Robotic Hysterectomy	3.0	± 2.4
Abdominal Hysterectomy	4.5	± 2.1

CK time 6

Group	Value	95% CI
Robotic Hysterectomy	1.0	± 0.6
Abdominal Hysterectomy	0.9	± 0.6

CK time 7

Group	Value	95% CI
Robotic Hysterectomy	1.6	± 1.1
Abdominal Hysterectomy	1.3	± 0.8

Changes in Biomarkers for Tissue Damage (Cortisol) Secondary · One week and just before surgery. Two, 24 and 48 hours postoperatively. One and six weeks after surgery.

Cortisol time 1

Group	Value	95% CI
Robotic Hysterectomy	273.4	± 75.0
Abdominal Hysterectomy	266.0	± 123.2

Cortisol time 2

Group	Value	95% CI
Robotic Hysterectomy	489.0	± 137.0
Abdominal Hysterectomy	510.1	± 131.2

Cortisol time 3

Group	Value	95% CI
Robotic Hysterectomy	301.0	± 267.0
Abdominal Hysterectomy	533.2	± 249.0

Cortisol time 4

Group	Value	95% CI
Robotic Hysterectomy	392.0	± 201.0
Abdominal Hysterectomy	383.0	± 178.1

Cortisol time 5

Group	Value	95% CI
Robotic Hysterectomy	358.1	± 128.0
Abdominal Hysterectomy	379.0	± 125.4

Cortisol time 6

Group	Value	95% CI
Robotic Hysterectomy	309.1	± 98.0
Abdominal Hysterectomy	331.0	± 76.0

Cortisol time 7

Group	Value	95% CI
Robotic Hysterectomy	307.0	± 129.0
Abdominal Hysterectomy	331.1	± 125.4

Health Economics (With 300 Robotic Procedures Annually) Secondary · From the day of surgery until six weeks after surgery.

Total costs (direct and indirect) for hospital stay and recovery period until six weeks postoperatively.

Direct costs per procedure

Group	Value	95% CI
Robotic Hysterectomy	65,728
Abdominal Hysterectomy	46,776

Indirect costs per procedure

Group	Value	95% CI
Robotic Hysterectomy	12,451
Abdominal Hysterectomy	18,318

Total costs (direct + indirect) per procedure

Group	Value	95% CI
Robotic Hysterectomy	78,179
Abdominal Hysterectomy	65,094

Health Economics (With 500 Robotic Procedures Annually) Secondary · From the day of surgery until six weeks after surgery.

Total costs (direct and indirect) for hospital stay and recovery period until six weeks postoperatively.

Direct costs per procedure

Group	Value	95% CI
Robotic Hysterectomy	61,862
Abdominal Hysterectomy	46,769

Indirect costs per procedure

Group	Value	95% CI
Robotic Hysterectomy	12,451
Abdominal Hysterectomy	18,318

Total costs (direct + indirect) per procedure

Group	Value	95% CI
Robotic Hysterectomy	74,313
Abdominal Hysterectomy	65,087

Adverse events — posted to ClinicalTrials.gov

Time frame: From the day of surgery until six weeks postoperatively.. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Robotic Hysterectomy

Serious: 0/25 (0%)

Deaths: 0/25

Abdominal Hysterectomy

Serious: 2/24 (8%)

Deaths: 0/24

Serious adverse events (2 terms)

Reaction	System	Robotic Hysterectomy	Abdominal Hysterectomy
Reoperation vaginal vault bleeding	Blood and lymphatic system disorders	—	—
Bladder injury	Injury, poisoning and procedural complications	—	—

Other adverse events (9 terms — click to expand)

Reaction	System	Robotic Hysterectomy	Abdominal Hysterectomy
Wound complications	Infections and infestations	—	—
Neuralgia	Nervous system disorders	—	—
Urinary tract infection	Infections and infestations	—	—
Constipation	Gastrointestinal disorders	—	—
Spinal punction not possible	Surgical and medical procedures	—	—
Urinary retention	Renal and urinary disorders	—	—
Vaginal vault hematoma	Blood and lymphatic system disorders	—	—
Red blood cell transfusion	Blood and lymphatic system disorders	—	—
Intubation difficulties	Surgical and medical procedures	—	—

Most-reported serious reactions: Reoperation vaginal vault bleeding, Bladder injury.

Data from ClinicalTrials.gov NCT01526655 adverse events section.

Sponsor's own description

The purpose of the trial is to determine whether robot assisted laparoscopic hysterectomy compared with abdominal hysterectomy in a fast track program gives a faster recovery postoperatively, causes less tissue damage and less effects on the immunological system, and is health economically cost-effective.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

Robot-assisted surgery in gynaecology.
Lawrie TA, Liu H, Lu D, Dowswell T, et al · · 2019 · cited 59× · PMID 30985921 · DOI 10.1002/14651858.cd011422.pub2
Robot-assisted surgery in gynaecology.
Liu H, Lawrie TA, Lu D, Song H, et al · · 2014 · cited 27× · PMID 25493418 · DOI 10.1002/14651858.cd011422

Verify or expand the search:

Other recruiting trials for Endometrial Cancer

Currently open trials in the same condition.

NCT07419841 — A Phase 1 Study of the Safety and Tolerability of CTX-10726 · Phase 1 · recruiting
NCT07382583 — Development of a Shared Decision Tool to Facilitate Uptake of the Levonorgestrel-releasing Intrauterine System for the P · recruiting
NCT07377734 — Intrauterine Injection of Type III Collage in FST of EC/AEH · Phase 2 · recruiting
NCT07319429 — Refining Fertility-sparing Treatment in Endometrial Carcinoma Based on Molecular Classification · Phase 2, PHASE3 · recruiting
NCT07397624 — Endoscopic Suture Gastroplasty (ESG) for Treatment of Obese Patients With Endometrial Cancer · recruiting

Other University Hospital, Linkoeping trials

Trials by the same sponsor.

NCT07275086 — Therapeutic Outcomes of Using Complementary Hand-based Treatment in Diabetes · NA · not yet recruiting
NCT07499024 — Evaluation of the Diagnostic Performance of the Testicular Workup for Ischemia and Suspected Torsion (TWIST) Score for A · recruiting
NCT07367776 — Patient Education in Osteoporosis (RCT-PATOS) · NA · recruiting
NCT07211295 — Accurate AI-based Characterisation of Surface Size, Depth and Tissue Composition in Hard-to-Heal Wounds · completed
NCT06869148 — Evaluation of Prioritized Assessment for Older Patients Living With Frailty Presenting to the Emergency Department · completed

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT01526655 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by University Hospital, Linkoeping
Last refreshed: 18 April 2024

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT01526655.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing